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BLOOD GROUPING REAGENTS ANTI-A (MONOCLONAL) ANTI-B (MONOCLONAL) ANTI-D (ANTI-D RH1) (MONOCLONAL) CONTROL REVERSE DILUENT ORTHO BIOVUE® SYSTEM (ABO-RH REVERSE GROUPING CASETTE) - INVIMA Registration 2fdc6b439ad9629f1c8e176cc0165679

Access comprehensive regulatory information for BLOOD GROUPING REAGENTS ANTI-A (MONOCLONAL) ANTI-B (MONOCLONAL) ANTI-D (ANTI-D RH1) (MONOCLONAL) CONTROL REVERSE DILUENT ORTHO BIOVUE® SYSTEM (ABO-RH REVERSE GROUPING CASETTE) (BLOOD GROUPING REAGENTS ANTI-A (MONOCLONAL) ANTI-B (MONOCLONAL) ANTI-D (ANTI-D RH1) (MONOCLONAL) CONTROL REVERSE DILUENT ORTHO BIOVUE® SYSTEM (ABO-RH REVERSE GROUPING CASETTE)) in the Colombia medical device market through Pure Global AI's free database. This III medical device is registered under INVIMA analysis ID 2fdc6b439ad9629f1c8e176cc0165679 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
2fdc6b439ad9629f1c8e176cc0165679
BLOOD GROUPING REAGENTS ANTI-A (MONOCLONAL) ANTI-B (MONOCLONAL) ANTI-D (ANTI-D RH1) (MONOCLONAL) CONTROL REVERSE DILUENT ORTHO BIOVUE® SYSTEM (ABO-RH REVERSE GROUPING CASETTE)
INVIMA Analysis ID: 2fdc6b439ad9629f1c8e176cc0165679
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Product Use / Uso del Producto
Spanish

PARA USO DIAGNÓSTICO IN VITRO. PRUEBA CUALITATIVA _x000D_ PARA LA DETERMINACIÓN DE LOS ANTÍGENOS DEL GRUPO _x000D_ SANGUINEO ABO Y D (RH1) EN LOS HEMATÍES HUMANOS Y _x000D_ PARA DETERMINACIÓN DE LOS ANTICUERPOS ESPERADOS _x000D_ DEL GRUPO SANGUÍNEO.

English

FOR IN VITRO DIAGNOSTIC USE. QUALITATIVE TEST _x000D_ FOR THE DETERMINATION OF GROUP _x000D_ ANTIGENS ABO AND D (RH1) BLOOD CELLS IN HUMAN RED BLOOD CELLS AND _x000D_ TO DETERMINE THE EXPECTED ANTIBODIES _x000D_ OF THE BLOOD GROUP.

Device Classification
Risk Class / Clase de Riesgo
III
Product Type (Spanish)
REACTIVO DIAGNOSTICO
Product Type (English)
DIAGNOSTIC REAGENT
Registration Information
Analysis ID
2fdc6b439ad9629f1c8e176cc0165679
Expire Date
June 11, 2029
Authorized Company / Fabricante
Name (English)
ORTHO - CLINICAL DIAGNOSTICS COLOMBIA S.A.S