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1) IMMAGE 800 2) Immunochemistry Systems UCAL Urine Protein Calibrator 3) Immunochemistry Systems CAL 1 Calibrator 1 4) Immunochemistry Systems CAL 2 Calibrator 2 5) Immunochemistry Systems CAL 3 Calibrator 3 6) CAL 5 PLUS, Calibrator 5 Plus 7) Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 8) APO CAL Apolipoprotein Calibrator 9) Immunochemistry Systems Level 1 Urine Protein Control 10) Immunochemistry Systems Level 2 Urine Protein Control 11) Vigil Protein Control Level 1 12) Vigil Protein Control Level 2 13) Vigil Protein Control Level 3

Argentina Medical Device Registration · 1) IMMAGE 800 2) Immunochemistry Systems UCAL Urine Protein Calibrator 3) Immunochemistry Systems CAL 1 Calibrator 1 4) Immunochemistry Systems CAL 2 Calibrator 2 5) Immunochemistry Systems CAL 3 Calibrator 3 6) CAL 5 PLUS, Calibrator 5 Plus 7) Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 8) APO CAL Apolipoprotein Calibrator 9) Immunochemistry Systems Level 1 Urine Protein Control 10) Immunochemistry Systems Level 2 Urine Protein Control 11) Vigil Protein Control Level 1 12) Vigil Protein Control Level 2 13) Vigil Protein Control Level 3 · BIODIAGNOSTICO S.A. · Registered July 17, 2024

IVD Registration Group A and B
Device classification
Registration Type
IVD Registration Group A and B
Registro IVD Grupo A y B
Product Code
1201-437
Brand Name
1) IMMAGE 800 2) Immunochemistry Systems UCAL Urine Protein Calibrator 3) Immunochemistry Systems CAL 1 Calibrator 1 4) Immunochemistry Systems CAL 2 Calibrator 2 5) Immunochemistry Systems CAL 3 Calibrator 3 6) CAL 5 PLUS, Calibrator 5 Plus 7) Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 8) APO CAL Apolipoprotein Calibrator 9) Immunochemistry Systems Level 1 Urine Protein Control 10) Immunochemistry Systems Level 2 Urine Protein Control 11) Vigil Protein Control Level 1 12) Vigil Protein Control Level 2 13) Vigil Protein Control Level 3
Product Name
1) IMMAGE 800 2) Immunochemistry Systems UCAL Urine Protein Calibrator 3) Immunochemistry Systems CAL 1 Calibrator 1 4) Immunochemistry Systems CAL 2 Calibrator 2 5) Immunochemistry Systems CAL 3 Calibrator 3 6) CAL 5 PLUS, Calibrator 5 Plus 7) Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 8) APO CAL Apolipoprotein Calibrator 9) Immunochemistry Systems Level 1 Urine Protein Control 10) Immunochemistry Systems Level 2 Urine Protein Control 11) Vigil Protein Control Level 1 12) Vigil Protein Control Level 2 13) Vigil Protein Control Level 3
Registration information
Registration Date
July 17, 2024
Database ID
cmhayu5bc0k8dekuz9x5minip
Authorized representative
Documents
Product information

1) IMMAGE 800 2) Immunochemistry Systems UCAL Urine Protein Calibrator 3) Immunochemistry Systems CAL 1 Calibrator 1 4) Immunochemistry Systems CAL 2 Calibrator 2 5) Immunochemistry Systems CAL 3 Calibrator 3 6) CAL 5 PLUS, Calibrator 5 Plus 7) Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 8) APO CAL Apolipoprotein Calibrator 9) Immunochemistry Systems Level 1 Urine Protein Control 10) Immunochemistry Systems Level 2 Urine Protein Control 11) Vigil Protein Control Level 1 12) Vigil Protein Control Level 2 13) Vigil Protein Control Level 3

About this record

Access comprehensive regulatory information for 1) IMMAGE 800 2) Immunochemistry Systems UCAL Urine Protein Calibrator 3) Immunochemistry Systems CAL 1 Calibrator 1 4) Immunochemistry Systems CAL 2 Calibrator 2 5) Immunochemistry Systems CAL 3 Calibrator 3 6) CAL 5 PLUS, Calibrator 5 Plus 7) Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 8) APO CAL Apolipoprotein Calibrator 9) Immunochemistry Systems Level 1 Urine Protein Control 10) Immunochemistry Systems Level 2 Urine Protein Control 11) Vigil Protein Control Level 1 12) Vigil Protein Control Level 2 13) Vigil Protein Control Level 3 in the Argentina medical device market through Pure Global AI's free database. This IVD Registration Group A and B medical device is registered with Argentina's ANMAT (National Administration of Drugs, Food and Medical Technology). The device was registered on July 17, 2024.

This page provides complete registration details including product code (1201-437), brand name (1) IMMAGE 800 2) Immunochemistry Systems UCAL Urine Protein Calibrator 3) Immunochemistry Systems CAL 1 Calibrator 1 4) Immunochemistry Systems CAL 2 Calibrator 2 5) Immunochemistry Systems CAL 3 Calibrator 3 6) CAL 5 PLUS, Calibrator 5 Plus 7) Immunochemistry Systems LPA CAL Lipoprotein(a) Calibrator 8) APO CAL Apolipoprotein Calibrator 9) Immunochemistry Systems Level 1 Urine Protein Control 10) Immunochemistry Systems Level 2 Urine Protein Control 11) Vigil Protein Control Level 1 12) Vigil Protein Control Level 2 13) Vigil Protein Control Level 3), authorized representative information, registration type, and regulatory compliance data from the official Argentina ANMAT medical device database. Pure Global AI offers free access to Argentina's medical device registry, helping global MedTech companies navigate Argentina regulations efficiently.

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