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PANBIO™ COVID-19 IGG RAPID TEST DEVICE - INVIMA Registration d62e55f353da3b02ecf55d48d39e95dd

Access comprehensive regulatory information for PANBIO™ COVID-19 IGG RAPID TEST DEVICE (PANBIO™ COVID-19 IGG RAPID TEST DEVICE) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID d62e55f353da3b02ecf55d48d39e95dd and manufactured by ABBOTT RAPID DIAGNOSTICS COLOMBIA S.A.S.

This page provides complete registration details including product type (DIAGNOSTIC REAGENT), authorised information, and regulatory compliance data from the official Colombia INVIMA medical device database. Pure Global AI offers free access to Colombia's complete medical device registry with bilingual Spanish/English support, helping global MedTech companies navigate INVIMA regulations efficiently.

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INVIMA Official Data
III
d62e55f353da3b02ecf55d48d39e95dd
PANBIO™ COVID-19 IGG RAPID TEST DEVICE
INVIMA Analysis ID: d62e55f353da3b02ecf55d48d39e95dd
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Product Use / Uso del Producto
Spanish

PANBIO™ COVI D-19 LGG RAPID TEST DEVICE ES UN INMUNOENSAYO DE FLUJO LATERAL RÁPIDO DISENADO PARA LA DETECCIÓN CUALITATIVA DE ANTICUERPOS DE INMUNOGLOBULINA (LGG) CONTRA LA PROTEÍNA DE LA ESPÍCULA DEL SARS-COV-2 EN SUERO, PLASMA, SANGRE VENOSA TOTAL Y MUESTRAS DE SANGRE TOTAL OBTENIDA POR PUNCION DIGITAL EN UN ENTORNO DE PRUEBAS O LABORATORIO CERCANO AL PACIENTE._x000D_ EL ENSAYO ESTA DISENADO PARA USARSE COMO AYUDA EN LA IDENTIFICACION DE PERSONAS CON UNA RESPUESTA INMUNITARIA ADAPTATIVA AL SARS-COV-2 O COMO AYUDA PARA EVALUAR EL ESTADO INMUNITARIO DE LAS PERSONAS DESPUES DE HABER RECIBIDO LA VACUNA CONTRA EL SARS-COV-2. PARA USO PROFESIONAL EXCLUSIVO.

English

PANBIO™ COVI D-19 LGG RAPID TEST DEVICE IS A RAPID LATERAL FLOW IMMUNOASSAY DESIGNED FOR THE QUALITATIVE DETECTION OF IMMUNOGLOBULIN (LGG) ANTIBODIES TO SARS-COV-2 SPIKE PROTEIN IN SERUM, PLASMA, WHOLE VENOUS BLOOD, AND WHOLE BLOOD SAMPLES OBTAINED BY FINGERSTICK IN A TESTING OR LABORATORY SETTING CLOSE TO THE PACIENTE._x000D_ THE TRIAL IS DESIGNED TO BE USED AS AN AID IN IDENTIFYING PEOPLE WITH AN ADAPTIVE IMMUNE RESPONSE TO SARS-COV-2 OR AS AN AID IN ASSESSING PEOPLE'S IMMUNE STATUS AFTER THEY HAVE RECEIVED THE SARS-COV-2 VACCINE. FOR PROFESSIONAL USE ONLY.

Device Classification
Risk Class / Clase de Riesgo
III
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
d62e55f353da3b02ecf55d48d39e95dd
Authorized Company / Fabricante
Name (English)
ABBOTT RAPID DIAGNOSTICS COLOMBIA S.A.S