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ORTHO™ SERA ANTI-D (DVI) - INVIMA Registration 787e9cfe543aa5f1082d56ea44b5685a

Access comprehensive regulatory information for ORTHO™ SERA ANTI-D (DVI) (Money™ Best Aunt-D (DVI)) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID 787e9cfe543aa5f1082d56ea44b5685a and manufactured by ORTHO - CLINICAL DIAGNOSTICS COLOMBIA S.A.S. The device was registered on June 11, 2029.

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
787e9cfe543aa5f1082d56ea44b5685a
ORTHO™ SERA ANTI-D (DVI)
INVIMA Analysis ID: 787e9cfe543aa5f1082d56ea44b5685a
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Product Use / Uso del Producto
Spanish

PARA USO DIAGNÓSTICO IN VITRO. PARA LA PRUEBA DE _x000D_ AGLUTINACIÓN DIRECTA MEDIANTE LA TÉCNICA DE _x000D_ AGLUTINACIÓN EN COLUMNA EL REACTIVO ANTI-D (DVI) _x000D_ ESTÁ DISEÑADO PARA LA DETECCIÓN CUALITATIVA IN _x000D_ VITRO DE HEMATÍES HUMANOS RHD POSITIVOS MEDIANTE_x000D_ LA PRUEBA DE AGLUTINACIÓN DIRECTA. ESTE REACTIVO _x000D_ ANTI-D DETECTARÁ CÉLULAS DVI DE CATEGORÍA D.

English

FOR IN VITRO DIAGNOSTIC USE. FOR _x000D_ TEST DIRECT AGGLUTINATION USING THE _x000D_ TECHNIQUE COLUMN AGGLUTINATION OF ANTI-D REAGENT (DVI) _x000D_ IT IS DESIGNED FOR QUALITATIVE DETECTION IN _x000D_ VITRO RHD-POSITIVE RED BLOOD CELLS MEDIANTE_x000D_ THE DIRECT AGGLUTINATION TEST. THIS REAGENT _x000D_ ANTI-D WILL DETECT CATEGORY D DVI CELLS.

Device Classification
Risk Class / Clase de Riesgo
III
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
787e9cfe543aa5f1082d56ea44b5685a
Expire Date
June 11, 2029
Authorized Company / Fabricante
Name (English)
ORTHO - CLINICAL DIAGNOSTICS COLOMBIA S.A.S