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"uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/41116105"}], "quantity": 54000, "unit": {"name": "Determinaci\u00f3n", "id": "DET", "value": {"amount": 15835, "currency": "PYG"}}, "relatedLot": "1ef706b2-519f-6248-b262-871354ef1606", "attributes": [{"value": "COREA DEL SUR", "name": "Procedencia", "id": "1"}, {"value": "ABBOTT DIAGNOSTIC KOREA INC", "name": "Fabricante", "id": "3"}, {"value": "BIOLINE", "name": "Marca", "id": "4"}, {"name": "Orden", "value": "4", "id": "7"}]}, {"id": "1ef706b4-3db3-6822-8111-d7db5d6806d9", "description": "TEST R\u00c1PIDO PARA HIV", "classification": {"scheme": "catalogoNivel5DNCP", "id": "41116205-9993", "description": "Test Rapido para HIV", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n5/41116205-9993"}, "additionalClassifications": [{"scheme": "UNSPSC", "id": "41116205", "description": "Kits de ensayos rapidos", "uri": "https://www.contrataciones.gov.py/datos/api/v3/doc/itemClassification/n4/41116205"}], "quantity": 50400, "unit": {"name": "Determinaci\u00f3n", "id": "DET", "value": {"amount": 4830, "currency": "PYG"}}, "relatedLot": "1ef706b4-3db0-6352-a9ba-d7db5d6806d9", "attributes": [{"value": "CHINA", "name": "Procedencia", "id": "1"}, {"value": "ABON BHIOPHARM(HANGZHOU)LTD", "name": "Fabricante", "id": "3"}, {"value": "ABON", "name": "Marca", "id": "4"}, {"name": "Orden", "value": "5", "id": "7"}]}]}], "tender": {"id": "1ef6ec6a-19dd-668c-91cf-a791a7e6835d", "title": "LPN N\u00b0 133/24 ADQUISICI\u00d3N DE REACTIVOS E INSUMOS PARA LABORATORIOS DEL IPS SOLPED 1140000320", "status": "complete", "awardCriteria": "priceOnly", "awardCriteriaDetails": "Por Item", "submissionMethod": ["inPerson"], "bidOpening": {"date": "2024-12-17T09:15:00-04:00", "address": {"streetAddress": "SALA DE APERTURAS CONSTITUCION Y HERRERA PRIMER PISO EDIFICIO CAJA CENTRAL"}}, "submissionMethodDetails": "Lugar entrega ofertas: CONSTITUCION Y HERRERA PRIMER PISO EDIFICIO CAJA CENTRAL DIRECCION OPERATIVA DE CONTRATACIONES", "eligibilityCriteria": "Restricciones: NINGUNA", "statusDetails": "Adjudicada", "enquiriesAddress": {"streetAddress": "A TRAVES DEL SICP"}, "clarificationMeetings": [{"address": {"streetAddress": "NO APLICA"}, "id": "1"}], "mainProcurementCategoryDetails": "Bienes - Equipo de Laboratorio Medida, Observacion y Comprobacion", "hasEnquiries": false, "value": {"amount": 8534242068, "currency": "PYG"}, "datePublished": "2024-10-04T18:52:34-04:00", "tenderPeriod": {"startDate": "2024-10-04T18:52:34-04:00", "endDate": "2024-12-17T09:00:00-04:00", "durationInDays": 73}, "awardPeriod": {"startDate": "2024-12-17T09:15:00-04:00"}, "contractPeriod": {"durationInDays": 720}, "enquiryPeriod": {"endDate": "2024-12-10T09:00:00-04:00", "startDate": "2024-10-04T18:52:34-04:00", "durationInDays": 66}, "mainProcurementCategory": "services", "additionalProcurementCategories": ["services"], "procurementMethod": "open", "procurementMethodDetails": "Licitaci\u00f3n P\u00fablica Nacional", "procuringEntity": {"id": "DNCP-SICP-CODE-157", "name": "Instituto de Previsi\u00f3n Social (IPS)"}, "criteria": [{"id": "1", "title": "Garant\u00eda de Mantenimiento de Ofertas", "description": "Los oferentes, proveedores o contratistas deber\u00e1n garantizar la seriedad de sus ofertas, mediante la garant\u00eda de mantenimiento de la oferta", "source": "tenderer", "requirementGroups": [{"id": "1-1", "description": "La garant\u00eda debe ser de un cierto porcentaje, periodo y tipo", "requirements": [{"id": "1-1-1", "title": "Porcentaje de la garantia", "expectedValue": "5"}, {"id": "1-1-2", "title": "Validez de la garantia en d\u00edas", "expectedValue": "180"}]}]}], "enquiries": [{"id": "3731e882614c6f9a85ebd5548a59657c-1", "date": "2024-11-13T20:41:46-04:00", "title": "item 6 EETT", "description": "La convocante solicita en la nueva versi\u00f3n del Pliego: INFLUENZA A / INFLUENZA B M\u00c9TODO: INMUNOCROMATOGRAFIA (TEST R\u00c1PIDO). KIT COMPLETO CON: DISPOSITIVOS DE PRUEBA (EN CASETTE O TIRAS) CON DESECANTE EN BOLSA DE ALUMINIO INDIVIDUAL O DE PL\u00c1STICO, SOLUCI\u00d3N TAMP\u00d3N (QUE INACTIVA\nEL VIRUS), TUBOS DE EXTRACCI\u00d3N, TAPAS PARA LOS TUBOS DE EXTRACCI\u00d3N, CONTROL POSITIVO, CONTROLNEGATIVO, HISOPOS NASOFARINGEOS ESTERILIZADOS PARA LA RECOLECCI\u00d3N DE MUESTRAS VIRALES CON MANGO FLEXIBLES, SOPORTE DE TUBOS. ENTRE OTROS INCLUYE A VIRUS SINCITIAL RESPIRATORIO, ADENOVIRUS,  PARAINFLUENZA 1,2, 3, (LISTA ENUNCIATIVA, NO LIMITATIVA) CERTIFICADO DE CALIDAD ISO O CE O FDA SARS-COV-2: KIT DE ENSAYO DE MEMBRANA INMUNOCROMATOGR\u00c1FICA QUE UTILICE ANTICUERPOS MONOCLONALES MUY SENSIBLES PARA DETECTAR LA PROTEINA DE LA NUCLEOC\u00c1PSIDE DEL SARS-COV-2 EN MUESTRAS DE HISOPADO\nNASOFARINGEO O NASAL. CONTENIENDO 20 CARTUCHOS DE PRUEBA\nCOMO MINIMO. 2 VIALES DE TAMP\u00d3N DE EXTRACCI\u00d3N, 20 HISOPOS EST\u00c9RILES COMO M\u00cdNIMO, 20 TUBOS Y PUNTAS DE EXTRACCI\u00d3N COMO M\u00cdNIMO. I ESTACI\u00d3N DE TRABAJO, INSTRUCTIVO. DEBE INCLUIR UN LINEA DE CONTROL TANTO PARA RESULTADOS POSITIVOS Y RESULTADOS NEGATIVOS. ESPECIFICIDAD SUPERIOR A 99% SENSIBILIDAD SUPERIOR A 97% TANTO PARA HISOPADO NASAL COMO NASOFARINGEO. ALMACENAMIENTO DE 2-30\u00b0C\nFavor aclarar si la convocante solicita dos kits uno que detecte:INFLUENZA A / INFLUENZA B, ENTRE OTROS INCLUYE A VIRUS SINCITIAL RESPIRATORIO, ADENOVIRUS, PARAINFLUENZA 1,2, 3, (LISTA ENUNCIATIVA, NO LIMITATIVA) y otro que detecte SARS-COV-2, y que este segundo kit no necesite ning\u00fan certificado de calidad tipo FDA o CE. O un solo kit en el cual detecte en simultaneo SARS-COV-2, INFLUENZA B, ENTRE OTROS INCLUYE A VIRUS SINCITIAL RESPIRATORIO, ADENOVIRUS, PARAINFLUENZA 1,2, 3, (LISTA ENUNCIATIVA, NO LIMITATIVA)", "answer": "Se aclara que se solicita un \u00fanico kit que permita la detecci\u00f3n simult\u00e1nea de los siguientes virus: SARS-CoV-2, Influenza A, Influenza B como m\u00ednimo.", "dateAnswered": "2024-11-26T08:16:40-04:00"}, {"id": "59ea80608f0dd76b3e9f8e8d39b9dcaf-1", "date": "2024-11-27T21:24:06-04:00", "title": "REQUISITOS DOCUMENTALES PARA EVALUAR EL CRITERIO DE CAPACIDAD T\u00c9CNICA", "description": "En el apartado de Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica, en el punto 2 \u2018Resoluci\u00f3n de apertura\u2019, se solicita a la convocante que se aclare qu\u00e9 documentos son necesarios para los distribuidores autorizados que importan productos de f\u00e1bricas ubicadas en el extranjero. Observamos que ninguno de los puntos mencionados hace referencia espec\u00edfica a este caso. \u00bfEn este contexto, se requerir\u00e1 \u00fanicamente la Copia Autenticada de la Resoluci\u00f3n de Apertura vigente, emitida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria del Ministerio de Salud P\u00fablica y Bienestar Social, para la comercializaci\u00f3n del Dispositivo M\u00e9dico seg\u00fan corresponda, por parte del proveedor?", "answer": "Se aclara que, en caso de que el oferente sea el representante autorizado del fabricante extranjero, ser\u00e1 suficiente la presentaci\u00f3n de la copia autenticada de la Resoluci\u00f3n de Apertura vigente del oferente, emitida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DNVS), que lo habilite para importar y/o comercializar el dispositivo m\u00e9dico ofertado.\nPor otro lado, si el oferente no es el distribuidor autorizado ni el representante del fabricante extranjero, se requerir\u00e1 la presentaci\u00f3n de la Resoluci\u00f3n de Apertura vigente tanto del oferente como del representante local del producto, de acuerdo con lo estipulado en el Pliego de Bases y Condiciones.\n", "dateAnswered": "2024-12-12T14:46:20-04:00"}, {"id": "d41a78f88b1d2949e45ca6a4ac2d22c0-1", "date": "2024-11-27T21:24:17-04:00", "title": "REQUISITOS DOCUMENTALES PARA EVALUAR EL CRITERIO DE CAPACIDAD T\u00c9CNICA", "description": "En el apartado de Requisitos documentales para evaluar el criterio de capacidad t\u00e9cnica, en el punto 3 \u2018Registro sanitario vigente\u2019, se solicita amablemente a la convocante excluir de este requerimiento a los \u00edtems 7 y 8, ya que dichos productos son insumos generales de laboratorio y, conforme a lo establecido en la Resoluci\u00f3n N\u00b0 266/24 de DINAVISA, no requieren registro sanitario para su comercializaci\u00f3n.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-12T14:46:29-04:00"}, {"id": "f3ee23061863b14ee3ea03ac93563b66-1", "date": "2024-10-09T22:08:48-04:00", "title": "CAPACIDAD TECNICA", "description": "En el punto 3, la convocante solicita que el oferente deber\u00e1 presentar el Registro Sanitario Vigente expedida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) En\ncaso de que las documentaciones antes mencionadas se encuentran vencidas, se deber\u00e1 acompa\u00f1ar Constancia emitida por la\nDINAVISA de que los mismos se encuentran en tr\u00e1mite de renovaci\u00f3n (Registro Sanitario). Teniendo en cuenta que nos encontramos en un proceso de transici\u00f3n de cambio entre Laboratorio Central y Dinavisa y el retraso importante que presenta Dinavisa en la emisi\u00f3n de alg\u00fan tipo de documento. Solicitamos a la convocante redactar el pedido para reactivos de la siguiente manera;\n 1) Certificado de venta libre del pa\u00eds de origen de cada determinaci\u00f3n ofertada. \n2)Certificado Vigente que autoriza la inscripci\u00f3n y funcionamiento de la empresa importadora de reactivos para diagn\u00f3sticos, emitido por el Laboratorio Central de Salud P\u00fablica del MSPyBS y /o\nDINAVISA seg\u00fan corresponda.\n3)Constancia de Inscripci\u00f3n del PDIV (Productos para Diagnostico de Uso In Vitro) expedida por la Direcci\u00f3n de Registros, Habilitaci\u00f3n y Control del Laboratorio Central de Salud P\u00fablica y/o DINAVISA\nseg\u00fan corresponda.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-11-01T07:44:44-04:00"}, {"id": "92ed1ba0606e6fb48f2afc13aec51b5c-1", "date": "2024-10-10T14:39:01-04:00", "title": "\u00cdtem 6", "description": "En la especificaci\u00f3n del test r\u00e1pido de virus respiratorios menciona lo siguinte \"INCLUIR UN LINEA DE CONTROL TANTO PARA RESULTADOS POSITIVOS Y RESULTADOS NEGATIVOS\", solicitamos a la convocante aclarar a que se refiere debido a  que los test r\u00e1pidos en general solo incluyen una l\u00ednea de control para validar la corrida y no as\u00ed l\u00edneas de controles positivos y negativos.", "answer": "Se aclara que se refiere al control interno, por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-11-01T07:45:38-04:00"}, {"id": "e0d6c32dd79bb1f919b2d801131475db-1", "date": "2024-10-09T09:41:30-04:00", "title": "ITEM 1", "description": "Se podria admitir un agar base salado de mannitol?", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-11-01T07:42:03-04:00"}, {"id": "e6b91ea077afdd0af4869d8df67bb1cc-1", "date": "2024-10-31T18:46:57-04:00", "title": "Item 6 - Especificaciones t\u00e9cnicas", "description": "Se solicita a la convocante aclarar la siguiente especificaci\u00f3n que establece \"ESPECIFICIDAD SUPERIOR A 99% SENSIBILIDAD SUPERIOR A 97% TANTO PARA HISOPADO NASAL COMO NASOFARINGEO.\", ya que el producto solicitado en este item incluye diversos virus respiratorios. Se solicita aclarar si esta especificaci\u00f3n se aplica a todos los virus solicitados, o solamente a SARS-COV-2.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-11-13T15:25:22-04:00"}, {"id": "5fc1691ec3f4f7ae5a6e74e8942a0612-1", "date": "2024-10-09T10:29:15-04:00", "title": "ITEM 8 PUNTERAS AZULES DESECHABLES", "description": "Se solicita a la convocante aclarar si lo solicitado corresponde a puntas de 200 a 1000 ul de volumen o se solicita puntas de 200 ul y 1000 ul por separado?", "answer": "Se aclara que lo solicitado es de 200 a 1000ul de volumen, esto es que pueden ofertarse cualesquiera siempre y cuando se encuentre en el rango solicitado, ya que las mismas cumplir\u00edan la funci\u00f3n deseada.", "dateAnswered": "2024-11-01T07:44:33-04:00"}, {"id": "8475b1f7b32afa534108004ff3c3c4c9-1", "date": "2024-11-20T17:14:29-04:00", "title": "CAPACIDAD TECNICA", "description": "Solicitamos a la Convocante aceptar constancia de estar en tramite de registro sanitario emitido por DINAVISA, a fin de brindar mayor oportunidad de participaci\u00f3n a los oferentes.", "answer": "El oferente deber\u00e1 remitirse al Pliego  \u00daltima Versi\u00f3n.", "dateAnswered": "2024-12-03T13:48:10-04:00"}, {"id": "69023b805e7d861fedffc90d63c86aee-1", "date": "2024-10-18T08:49:19-04:00", "title": "Certificado de Buenas practicas", "description": "EL pliego de bases y condiciones solicita en la capacidad t\u00e9cnica punto 3: Certificado de Buenas Pr\u00e1cticas de almacenamiento y dep\u00f3sito, emitido por el MSP y BS, el cual deber\u00e1 estar vigente durante toda la duraci\u00f3n del contrato. Solicitamos excluir dicho requisito debido a que en un proceso anterior ID N\u00b0 435074 y Resoluci\u00f3n DNCP N\u00b0 2263/24, la convocante ya se ha expedido a dicha solicitud atendiendo a la veracidad de lo expuesto.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-11-01T07:46:01-04:00"}, {"id": "25028094ef4783f1a45b72ef15e7cc77-2", "date": "2024-11-20T17:10:11-04:00", "title": "CAPACIDAD TECNICA", "description": "En el punto 3 el pliego solicita: El oferente deber\u00e1 presentar el Registro Sanitario Vigente expedida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) En caso de que las documentaciones antes mencionadas se encuentran vencidas, se deber\u00e1 acompa\u00f1ar Constancia emitida por la DINAVISA de que los mismos se encuentran en tr\u00e1mite de renovaci\u00f3n (Registro Sanitario). Se solicita modificar dicho punto admitiendo la Constancia emitida por Laboratorio Central de Salud Publica, pues se halla vigente el Informativo DINAVISA 05/2023 cuyo texto reproducimos a continuaci\u00f3n: \u201cINFORMATIVO DINAVISA N.\u00b0 05/2023. Resaltamos una parte del documento \"...La constancia expedida por la mencionada instituci\u00f3n, mantendr\u00e1 su vigencia hasta el vencimiento de la habilitaci\u00f3n de la empresa establecida en dicha constancia, posterior a este vencimiento deber\u00e1n contar indefectiblemente con Registro Sanitario...\"", "answer": "EL OFERENTE DEBER\u00c1 REMITIRSE AL PLIEGO DE BASES Y CONDICIONES .ULTIMA VERSI\u00d3N", "dateAnswered": "2024-12-03T14:33:40-04:00"}, {"id": "43c12e0092b490fcf929f7ac0b79445e-1", "date": "2024-11-27T08:20:49-04:00", "title": "ITEM 6  especificaciones tecnicas, DETECCI\u00d3N SIMULTANEA DE ANT\u00cdGENOS DE SARS-COV- 2/INFLUENZA A/INFLUENZA B Y OTROS VIRUS RESPIRATORIOS", "description": "Se solicita a la convocante aclarar si lo solicitado es lo indicado en la descripcion del producto o en las especificaciones tecnicas, debido a que \u00e9stas no coinciden entre si", "answer": "Se aclara que  La descripci\u00f3n del producto indica de manera general el objetivo y alcance del reactivo solicitado: \"Reactivos para la detecci\u00f3n simult\u00e1nea de ant\u00edgenos de SARS-CoV-2, Influenza A, Influenza B y otros virus respiratorios mediante el m\u00e9todo de inmunocromatograf\u00eda (test r\u00e1pido)\".\nPor su parte, las especificaciones t\u00e9cnicas detallan los componentes espec\u00edficos que debe incluir el kit ofrecido para garantizar su funcionalidad, como dispositivos de prueba, soluci\u00f3n tamp\u00f3n, controles positivo y negativo, hisopos, entre otros. Asimismo, se especifica que, adem\u00e1s de los virus mencionados, el reactivo debe incluir la detecci\u00f3n de otros virus respiratorios como virus sincitial respiratorio, adenovirus, y parainfluenza (lista enunciativa, no limitativa).\n", "dateAnswered": "2024-12-12T14:45:53-04:00"}, {"id": "b75050cf817a5c25e03789cc3980d277-1", "date": "2024-11-08T11:32:32-04:00", "title": "ITEM 6  test rapido de virus respitatorios", "description": "Se podria admitir un test rapido de virus respitatorios cuya sensibilidad sea del 95.1%, y especificidad sea del 98%?", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-11-15T13:18:30-04:00"}, {"id": "001b224d5119300d670aaa17ebb6d02c-1", "date": "2024-10-09T09:41:41-04:00", "title": "ITEM 4 test de dengue antigeno", "description": "Se podria admitir un test de dengue antigeno NS1 con sensibilidad del 1ng/mL como m\u00ednimo? O del 80% como m\u00ednimo?", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-11-01T07:43:32-04:00"}, {"id": "db5714719928d63a5f2facfda3cbe334-1", "date": "2024-11-28T09:22:12-04:00", "title": "ITEM 7 - Especificaciones t\u00e9cnicas", "description": "Se solicita a la convocante, aclarar lo solicitado como especificaci\u00f3n t\u00e9cnica \"resistente a solventes\", ya que existe una diversa cantidad de solventes de origen qu\u00edmico, se solicita a la convocante aclarar a qu\u00e9 tipo de solventes se refiere, o esclarecer el criterio a tener en cuenta para evaluar este \u00edtem.", "answer": "Se aclara que dicha condici\u00f3n hace referencia a la capacidad del material de las pipetas de soportar la exposici\u00f3n a una amplia gama de solventes qu\u00edmicos com\u00fanmente utilizados en laboratorio, tales como solventes org\u00e1nicos y solventes inorg\u00e1nicos, sin que se vean afectadas sus propiedades funcionales (como deformaci\u00f3n, fragilidad o degradaci\u00f3n), por lo que el Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-12T14:47:02-04:00"}, {"id": "0b5f3df9fea8a1ac2d51233ee7c1e892-1", "date": "2024-10-31T18:47:14-04:00", "title": "Item 6 - Especificaciones t\u00e9cnicas", "description": "Se solicita a la convocante, modificar la solicitud de sensibilidad superior a 99%, ya que en la Licitaci\u00f3n anterior este criterio no era excluyente para la adjudicaci\u00f3n de los productos solicitados. Se solicita admitir una sensbilidad superior a 95%, para permitir una mayor participaci\u00f3n de\u00a0los\u00a0oferentes.", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-11-13T15:25:31-04:00"}, {"id": "25028094ef4783f1a45b72ef15e7cc77-1", "date": "2024-11-20T17:10:11-04:00", "title": "CAPACIDAD TECNICA", "description": "En el punto 3 el pliego solicita: El oferente deber\u00e1 presentar el Registro Sanitario Vigente expedida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) En caso de que las documentaciones antes mencionadas se encuentran vencidas, se deber\u00e1 acompa\u00f1ar Constancia emitida por la DINAVISA de que los mismos se encuentran en tr\u00e1mite de renovaci\u00f3n (Registro Sanitario). Se solicita modificar dicho punto admitiendo la Constancia emitida por Laboratorio Central de Salud Publica, pues se halla vigente el Informativo DINAVISA 05/2023 cuyo texto reproducimos a continuaci\u00f3n: \u201cINFORMATIVO DINAVISA N.\u00b0 05/2023. Resaltamos una parte del documento \"...La constancia expedida por la mencionada instituci\u00f3n, mantendr\u00e1 su vigencia hasta el vencimiento de la habilitaci\u00f3n de la empresa establecida en dicha constancia, posterior a este vencimiento deber\u00e1n contar indefectiblemente con Registro Sanitario...\"", "answer": "El oferente deber\u00e1 remitirse al Pliego  \u00daltima Versi\u00f3n.", "dateAnswered": "2024-12-03T13:48:05-04:00"}, {"id": "2af7725639ee3355b5c320aa418ac764-1", "date": "2024-11-27T15:49:49-04:00", "title": "CAPACIDAD TECNICA", "description": "PUNTO 3-El oferente deber\u00e1 presentar el Registro Sanitario Vigente expedida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) En\ncaso de que las documentaciones antes mencionadas se encuentran vencidas, se deber\u00e1 acompa\u00f1ar Constancia emitida por la\nDINAVISA de que los mismos se encuentran en tr\u00e1mite de renovaci\u00f3n (Registro Sanitario).  \nAL respecto actualmente los PDIV (reactivos) est\u00e1n pasando a ser parte de la Direcci\u00f3n Nacional de Vigilancia Sanitaria (Dinavisa), con la salvedad realizada por la misma DINAVISA \n a traves del  Informativo DINAVISA 05/2023 cuyo texto reproducimos a continuaci\u00f3n: \u201cINFORMATIVO DINAVISA N.\u00b0 05/2023. Resaltamos una parte del documento \"...La constancia expedida por la mencionada instituci\u00f3n (LCSP), mantendr\u00e1 su vigencia hasta el vencimiento de la habilitaci\u00f3n de la empresa establecida en dicha constancia, posterior a este vencimiento deber\u00e1n contar indefectiblemente con Registro Sanitario ( que debera estar emitido por Dinavisa). Es decir que los PDIV (reactivos) que se encuentran registrados en el Laboratorio Central de Salud P\u00fablica (LCSP), tienen validez hasta el vencimiento que consta en la mencionada constancia emitida por LCSP.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-12T14:46:11-04:00"}, {"id": "0580d4ea1ff1420089bd1a85fbe12cca-1", "date": "2024-11-28T09:22:01-04:00", "title": "ITEM 5 - Especificaciones t\u00e9cnicas", "description": "Se solicita a la convocante admitir una sensibilidad y especificidad m\u00ednima de 95%, ya que el objetivo de los test inmunocromatogr\u00e1ficos es el de tamizaje inicial de posibles infecciones, y no se consideran m\u00e9todos de confirmaci\u00f3n diagn\u00f3stica de las posibles enfermedades infecciosas. Se considera que con este porcentaje se puede lograr un alto grado de grado de confiabilidad para esta etapa preliminar, permitiendo identificar de manera eficaz los casos sospechosos que posteriormente deber\u00e1n confirmarse mediante pruebas de referencia m\u00e1s avanzadas, como ELISA o Western Blot.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-12T14:46:53-04:00"}, {"id": "fa4cdf77cce0419bb5b623a185ac835b-1", "date": "2024-10-10T10:01:15-04:00", "title": "ITEM 3= ANTIGENO DENGUE e ITEM 4= DENGUE TEST RAPIDO", "description": "Podria la convocante dar la opci\u00f3n de ofertar  el TEST  que ya viene con el antigeno (NS1) + igM e igG...?   EN COMBO..    Teniendo en cuenta la practicidad ( para la instituci\u00f3n y quienes la usan) y mejor costo para el estado.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-11-01T07:45:28-04:00"}, {"id": "8591267279ec4a555adb10221da6524b-1", "date": "2024-10-18T08:49:15-04:00", "title": "Capacidad T\u00e9cnica:", "description": "La convocante solicita en el punto \u201c4. Copia autenticada del Certificado de Registro o Inscripci\u00f3n vigente del producto ofertado o constancia de que se halla en tr\u00e1mite de renovaci\u00f3n, expedido por DINAVISA o por el Laboratorio Central del MSP y BS\u201d. Teniendo en cuenta que nos encontramos en un proceso de transici\u00f3n de cambio entre Laboratorio Central y Dinavisa teniendo un retraso importante Dinavisa en la emisi\u00f3n de dicho documento. Solicitamos a la convocante o excluir dicho requisito o modificar por el Certificado de libre venta tal y como se est\u00e1 estableciendo en la LPN N\u00b0 160/24 \u2013 ID N\u00b0 454803, LPN SBE 39-23 \u2013 ID N\u00b0 432638 de la misma convocante.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-11-01T07:45:50-04:00"}, {"id": "e665385656564a5539851e7aa3ead8a0-1", "date": "2024-11-27T15:49:41-04:00", "title": "CAPACIDAD TECNICA", "description": "SOLICITAMOS A LA CONVOCANTE ADECUAR LOS REQUISITOS DEL PLIEGO, SEGUN LO SOLICITADO.. EN EL SENTIDO DE DIFERENCIAR BIEN QUE DOCUMENTOS REQUIEREN QUE SE PRESENTE PARA LA PROVISI\u00d3N DE REACTIVOS Y QUE DOCUMENTOS REQUIEREN PARA LA PROVISI\u00d3N DE  INSUMOS Y QUE REQUIEREN PARA AMBOS CASOS. TAL COMO LO SOLICITAN EN OTRAS INSTITUCIONES. EJ; MSP ID 453.717 ( datos para verificarlos y tomarlos como ejemplo)", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-12T14:46:04-04:00"}, {"id": "dadfca5e46cadf1a1d184c2294606d75-1", "date": "2024-10-09T09:41:38-04:00", "title": "ITEM 3 test de dengue", "description": "Se podria admitir un test de dengue antigeno NS1 con sensibilidad del 1ng/mL como m\u00ednimo?", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-11-01T07:43:21-04:00"}, {"id": "8475b1f7b32afa534108004ff3c3c4c9-2", "date": "2024-11-20T17:14:29-04:00", "title": "CAPACIDAD TECNICA", "description": "Solicitamos a la Convocante aceptar constancia de estar en tramite de registro sanitario emitido por DINAVISA, a fin de brindar mayor oportunidad de participaci\u00f3n a los oferentes.", "answer": "EL OFERENTE DEBER\u00c1 REMITIRSE AL PLIEGO DE BASES Y CONDICIONES .ULTIMA VERSI\u00d3N", "dateAnswered": "2024-12-03T14:33:50-04:00"}, {"id": "bd36aa1bbb885232a5986f4d28980f3c-1", "date": "2024-11-27T08:20:46-04:00", "title": "ITEM 5 test rapido de HIV", "description": "Se podria admitir un test rapido de HIV 1/2 anticuerpos que admita solo muestras de suero o plasma, considerando que \u00e9stas son las muestras mayoritariamente utilizadas en el laboratorio?", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-12T14:45:40-04:00"}, {"id": "3c8616cdf0351e2abd88459254bb97bd-1", "date": "2024-10-09T09:41:50-04:00", "title": "ITEM 7 pipetas pasteur", "description": "Se solicita a la convocante aclarar pipetas pasteur de que volumen seria lo requerido ya que en las especificaciones t\u00e9cnicas no se aclara", "answer": "Se aclara que podr\u00eda ofertarse cualquier medida, que cumplir\u00edan de igual manera la funci\u00f3n a la cual est\u00e1 destinada.", "dateAnswered": "2024-11-01T07:44:15-04:00"}, {"id": "51b854892e8188e671824d1051557bd3-1", "date": "2024-10-09T09:41:47-04:00", "title": "ITEM 6  test r\u00e1pido de virus respiratorios", "description": "Se podria admitir un test r\u00e1pido de virus respiratorios que incluya flua + flub + rsv como minimo? Con sensibilidad y especificidad >99%?", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-11-01T07:43:51-04:00"}, {"id": "1dcc22d8dd6639f16671427f7c04f0f5-1", "date": "2024-10-09T09:41:43-04:00", "title": "ITEM 5  test r\u00e1pido de HIV", "description": "Se podria admitir un test r\u00e1pido de HIV 1/2 anticuerpos con sensibilidad de >99%, que admita muestras de suero y plasma?", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-11-01T07:43:41-04:00"}, {"id": "bfdc1b810d96a4ae530213c18bd1acb0-1", "date": "2024-11-27T21:24:22-04:00", "title": "Especificaciones Tecnicas", "description": "En el apartado de Especificaciones t\u00e9cnicas \u2013 CPS, en el item 5 (TEST R\u00c1PIDO PARA HIV I \u2013 II), donde dice: \u2018TEST R\u00c1PIDO CUALITATIVO PARA DETECCI\u00d3N DE ANTICUERPOS PARA VIRUS HIV I -II POR M\u00c9TODO CROMATOGR\u00c1FICO U OTRO SIMILAR EN SUERO, PLASMA O SANGRE TOTAL, CON CONTROL INTERNO QUE PERMITAN OBTENER RESULTADOS CONFIABLES Y DE F\u00c1CIL INTERPRETACI\u00d3N. SENSIBILIDAD M\u00cdNIMA A 98% Y ESPECIFICIDAD M\u00cdNIMA A 98%\u2019. Se solicita amablemente a la convocante admitir test que no cuenten con control interno, dado que estos est\u00e1n dise\u00f1ados espec\u00edficamente para tamizaje y poseen una alta sensibilidad y especificidad, garantizando resultados confiables. Adicionalmente, se proveer\u00e1n certificados de calidad internacionales, como FDA, ISO o CE, que respaldan el cumplimiento de los est\u00e1ndares regulatorios y de calidad necesarios para su uso.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-12T14:46:34-04:00"}, {"id": "86fbc09deb3f1682eb6da3786c5543f1-1", "date": "2024-11-27T08:20:43-04:00", "title": "ITEM 1 AGAR MANITOL", "description": "Se podria admitir un mannitol salado agar base en presentaci\u00f3n de 500 gramos?", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-12T14:45:29-04:00"}, {"id": "2e34fc7e6c7cfc480b3ad2f5125bb865-1", "date": "2024-11-13T20:20:19-04:00", "title": "capacidad tecnica", "description": "Capacidad tecnica requiere:\n3-El oferente deber\u00e1 presentar el Registro Sanitario Vigente expedida por la Direcci\u00f3n Nacional de Vigilancia Sanitaria (DINAVISA) En caso de que las documentaciones antes mencionadas se encuentran vencidas, se deber\u00e1 acompa\u00f1ar Constancia emitida por la\nDINAVISA de que los mismos se encuentran en tr\u00e1mite de renovaci\u00f3n (Registro Sanitario). Se solicita modificar dicho punto admitiendo la Constancia emitida por Lab Central, pues se halla vigente el Informativo DINAVISA 05/2023 cuyo texto reproducimos a continuaci\u00f3n: \u201cINFORMATIVO DINAVISA N.\u00b0 05/2023. La DIRECCI\u00d3N NACIONAL DE VIGILANCIA SANITARIA informa que, durante la etapa de transici\u00f3n e implementaci\u00f3n de la Resoluci\u00f3n DINAVISA N\u00b0 266/22, y con el objetivo de mantener la disponibilidad de los Productos para Diagn\u00f3stico de Uso In vitro en el mercado y en los servicios de salud, se reconocer\u00e1 para los tr\u00e1mites de solicitud de importaci\u00f3n, la constancia de inscripci\u00f3n emitida por el Laboratorio Central de Salud P\u00fablica del Ministerio de Salud P\u00fablica y Bienestar Social para los productos mencionados. La constancia expedida por la mencionada instituci\u00f3n, mantendr\u00e1 su vigencia hasta el vencimiento de la habilitaci\u00f3n de la empresa establecida en dicha constancia, posterior a este vencimiento deber\u00e1n contar indefectiblemente con Registro Sanitario", "answer": "El Oferente deber\u00e1 remitirse al Pliego \u00daltima Versi\u00f3n.", "dateAnswered": "2024-11-26T08:16:25-04:00"}, {"id": "b1726d51d200c89233d5937e9feadea4-1", "date": "2024-10-09T09:41:34-04:00", "title": "ITEM 2", "description": "Se podria admitir un agar base sangre azida?", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones. ", "dateAnswered": "2024-11-01T07:42:31-04:00"}, {"id": "72ab60ed440a37904a67d023750b5e96-1", "date": "2024-11-27T21:24:26-04:00", "title": "Plan de entrega de los bienes", "description": "En el apartado de Plan de entrega de los bienes, se solicita amablemente a la convocante considerar la ampliaci\u00f3n del plazo de entrega de los bienes, tanto para las cantidades m\u00ednimas como m\u00e1ximas, a un periodo no menor a 40 d\u00edas calendario. Los plazos actuales de 5 y 15 d\u00edas, respectivamente, resultan poco realistas dado el volumen de productos requeridos en la licitaci\u00f3n.\nEste ajuste es necesario para contemplar los tiempos habituales de fabricaci\u00f3n, exportaci\u00f3n y despacho de los productos, los cuales f\u00e1cilmente exceden un mes. De lo contrario, las condiciones actuales limitan la participaci\u00f3n \u00fanicamente a oferentes con stock disponible, restringiendo as\u00ed la competencia y favoreciendo a un grupo reducido de proveedores.", "answer": "El Oferente deber\u00e1 ajustarse a lo establecido en el Pliego de Bases y Condiciones.", "dateAnswered": "2024-12-12T14:46:46-04:00"}, {"id": "a87852ab4517561eef78dc68fed1f6ba-1", "date": "2024-10-09T22:24:32-04:00", "title": "ESPECIFICACIONES TECNICAS..", "description": "En el lote 6 -REACTIVO PARA VIRUS RESPIRATORIO\nReactivo para la detecci\u00f3n simultanea de antigenos  SARS COV2, INFLUENZA A Y B y Virus sincitial.. ( al decir LA LISTA ES ENUNCIATIVA, NO LIMITATIVA) se entiende que  si el test ofertado ya detecta SARS COV2, INFLUENZA A Y  B  y VIRUS SINCITIAL  estaria correcto???", "answer": "Se aclara que el El prop\u00f3sito del requisito es asegurar que el reactivo ofertado cumpla con la capacidad de detecci\u00f3n simult\u00e1nea de ant\u00edgenos de SARS COV2, Influenza A y B, y Virus Sincitial. La menci\u00f3n de que \"la lista es enunciativa, no limitativa\" implica que si bien estos virus deben estar incluidos, no se excluye la posibilidad de que el test tambi\u00e9n pueda detectar otros agentes virales. Sin embargo, lo fundamental y obligatorio es que el reactivo detecte los virus mencionados: SARS COV2, Influenza A y B, y Virus Sincitial.", "dateAnswered": "2024-11-01T07:45:14-04:00"}], "lots": [{"id": "1ef706b2-519f-6248-b262-871354ef1606", "title": "4 - 4 - DENGUE TEST RAPIDO", "status": "active", "statusDetails": "activo", "value": {"amount": 1043442000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "4", "id": "4"}]}, {"id": "1ef706b7-812f-6a76-ae23-49c07be85a3d", "title": "7 - 7 - PIPETAS PASTEUR", "status": "active", "statusDetails": "activo", "value": {"amount": 24860000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "7", "id": "7"}]}, {"id": "1ef706ad-0b87-612a-9caa-4b78bf32c20f", "title": "2 - 2 - Agar sangre acida", "status": "active", "statusDetails": "activo", "value": {"amount": 11767200, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "2", "id": "2"}]}, {"id": "1ef706b5-e60b-62bc-87c7-01d33df36878", "title": "6 - 6 - REACTIVO PARA VIRUS RESPIRATORIO", "status": "active", "statusDetails": "activo", "value": {"amount": 4033582000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "6", "id": "6"}]}, {"id": "1ef706b4-3db0-6352-a9ba-d7db5d6806d9", "title": "5 - 5 - TEST R\u00c1PIDO PARA HIV", "status": "active", "statusDetails": "activo", "value": {"amount": 343677600, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "5", "id": "5"}]}, {"id": "1ef706b0-76c4-6a16-b482-497a903871e5", "title": "3 - 3 - ANTIGENO DENGUE", "status": "active", "statusDetails": "activo", "value": {"amount": 3060311700, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "3", "id": "3"}]}, {"id": "1ef706b9-1c6b-650c-8305-7be6c1ee000d", "title": "8 - 8 - PUNTERAS PARA MICROPIPETA", "status": "active", "statusDetails": "activo", "value": {"amount": 6552000, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "8", "id": "8"}]}, {"id": "1ef706a1-fefd-6748-b3ad-95be65fce726", "title": "1 - 1 - Agar Manitol", "status": "active", "statusDetails": "activo", "value": {"amount": 10049568, "currency": "PYG"}, "openContractType": "cantidad", "simultaneousSupply": false, "attributes": [{"name": "Orden", "value": "1", "id": "1"}]}], "items": [{"id": "1ef706b5-e60d-65da-bc8f-01d33df36878", "description": "REACTIVO PARA VIRUS RESPIRATORIO", "classification": {"scheme": "catalogoNivel5DNCP", "id": "41116205-9989", "description": "Test Rapido - Virus Respiratorio", "uri": 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