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I) INSTRUMENTO 1) Chemiluminescence Immunoassay Analyzer II) REACTIVOS 2) iFlash-T4 3) iFlash-FT4 4) iFlash-T3 5) iFlash-FT3 6) iFlash-TSH 7) iFlash-Tg 8) iFlash-Anti-Tg 9) iFlash-Anti-TPO 10) iFlash-Anti-TSHR III) CONTROLES 11) Immunoassay Multi Control 12) Anti-TSHR Control IV) REACTIVOS ACCESORIOS 13) Wash Buffer (1x) 14) Wash Buffer (10x) 15) Pre-Trigger Solution 16) Trigger Solution 17) iFlash Cleaning Solution

Argentina Medical Device Registration · I) INSTRUMENTO 1) Chemiluminescence Immunoassay Analyzer II) REACTIVOS 2) iFlash-T4 3) iFlash-FT4 4) iFlash-T3 5) iFlash-FT3 6) iFlash-TSH 7) iFlash-Tg 8) iFlash-Anti-Tg 9) iFlash-Anti-TPO 10) iFlash-Anti-TSHR III) CONTROLES 11) Immunoassay Multi Control 12) Anti-TSHR Control IV) REACTIVOS ACCESORIOS 13) Wash Buffer (1x) 14) Wash Buffer (10x) 15) Pre-Trigger Solution 16) Trigger Solution 17) iFlash Cleaning Solution · BIOARS S.A. · Registered July 17, 2024

IVD Modification Group A and B
Device classification
Registration Type
IVD Modification Group A and B
Modificación IVD Grupo A y B
Product Code
1127-385
Brand Name
I) INSTRUMENTO 1) Chemiluminescence Immunoassay Analyzer II) REACTIVOS 2) iFlash-T4 3) iFlash-FT4 4) iFlash-T3 5) iFlash-FT3 6) iFlash-TSH 7) iFlash-Tg 8) iFlash-Anti-Tg 9) iFlash-Anti-TPO 10) iFlash-Anti-TSHR III) CONTROLES 11) Immunoassay Multi Control 12) Anti-TSHR Control IV) REACTIVOS ACCESORIOS 13) Wash Buffer (1x) 14) Wash Buffer (10x) 15) Pre-Trigger Solution 16) Trigger Solution 17) iFlash Cleaning Solution
Product Name
I) INSTRUMENTO 1) Chemiluminescence Immunoassay Analyzer II) REACTIVOS 2) iFlash-T4 3) iFlash-FT4 4) iFlash-T3 5) iFlash-FT3 6) iFlash-TSH 7) iFlash-Tg 8) iFlash-Anti-Tg 9) iFlash-Anti-TPO 10) iFlash-Anti-TSHR III) CONTROLES 11) Immunoassay Multi Control 12) Anti-TSHR Control IV) REACTIVOS ACCESORIOS 13) Wash Buffer (1x) 14) Wash Buffer (10x) 15) Pre-Trigger Solution 16) Trigger Solution 17) iFlash Cleaning Solution
Registration information
Registration Date
July 17, 2024
Database ID
cmhaytq49073eekuzp0o2g4j5
Authorized representative
Documents
Product information

I) INSTRUMENTO 1) Chemiluminescence Immunoassay Analyzer Modelos: iFlash 1800-A iFlash 3000-C

About this record

Access comprehensive regulatory information for I) INSTRUMENTO 1) Chemiluminescence Immunoassay Analyzer II) REACTIVOS 2) iFlash-T4 3) iFlash-FT4 4) iFlash-T3 5) iFlash-FT3 6) iFlash-TSH 7) iFlash-Tg 8) iFlash-Anti-Tg 9) iFlash-Anti-TPO 10) iFlash-Anti-TSHR III) CONTROLES 11) Immunoassay Multi Control 12) Anti-TSHR Control IV) REACTIVOS ACCESORIOS 13) Wash Buffer (1x) 14) Wash Buffer (10x) 15) Pre-Trigger Solution 16) Trigger Solution 17) iFlash Cleaning Solution in the Argentina medical device market through Pure Global AI's free database. This IVD Modification 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 (1127-385), brand name (I) INSTRUMENTO 1) Chemiluminescence Immunoassay Analyzer II) REACTIVOS 2) iFlash-T4 3) iFlash-FT4 4) iFlash-T3 5) iFlash-FT3 6) iFlash-TSH 7) iFlash-Tg 8) iFlash-Anti-Tg 9) iFlash-Anti-TPO 10) iFlash-Anti-TSHR III) CONTROLES 11) Immunoassay Multi Control 12) Anti-TSHR Control IV) REACTIVOS ACCESORIOS 13) Wash Buffer (1x) 14) Wash Buffer (10x) 15) Pre-Trigger Solution 16) Trigger Solution 17) iFlash Cleaning Solution), 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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