1127-137

1) ANA Detect 2) Anti-dsDNA IgA 3) Anti-dsDNA IgG 4) Anti-dsDNA IgM 5) Anti-dsDNA Screen 6) Anti-ssDNA 7) ENAscreen 8) Anti-Histone 9) Anti-SS-A 10) Anti-SS-B 11) Anti-Sm 12) Anti-RNP/Sm 13) Anti-Scl-70 14) Anti-Jo-1 15) Anti-Rib-P 16) Rheumatoid Factor IgA 17) Rheumatoid Factor IgG 18) Rheumatoid Factor IgM 19) Rheumatoid Factor Screen 20) Anti-Nucleosome 21) Anti-RNP-70 22) Anti-Centromere B 23) ANAscreen 24) Anti-alpha-Fodrin IgA 25) Anti-alpha-Fodrin IgG 26) Anti-MCV 27) Anti-C1q 28) Anti-SS-A 52 29) Anti-SS-A 60

Argentina Medical Device Registration · 1) ANA Detect 2) Anti-dsDNA IgA 3) Anti-dsDNA IgG 4) Anti-dsDNA IgM 5) Anti-dsDNA Screen 6) Anti-ssDNA 7) ENAscreen 8) Anti-Histone 9) Anti-SS-A 10) Anti-SS-B 11) Anti-Sm 12) Anti-RNP/Sm 13) Anti-Scl-70 14) Anti-Jo-1 15) Anti-Rib-P 16) Rheumatoid Factor IgA 17) Rheumatoid Factor IgG 18) Rheumatoid Factor IgM 19) Rheumatoid Factor Screen 20) Anti-Nucleosome 21) Anti-RNP-70 22) Anti-Centromere B 23) ANAscreen 24) Anti-alpha-Fodrin IgA 25) Anti-alpha-Fodrin IgG 26) Anti-MCV 27) Anti-C1q 28) Anti-SS-A 52 29) Anti-SS-A 60 · BIOARS S.A. · Registered May 27, 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: 1127-137
Brand Name: 1) ANA Detect 2) Anti-dsDNA IgA 3) Anti-dsDNA IgG 4) Anti-dsDNA IgM 5) Anti-dsDNA Screen 6) Anti-ssDNA 7) ENAscreen 8) Anti-Histone 9) Anti-SS-A 10) Anti-SS-B 11) Anti-Sm 12) Anti-RNP/Sm 13) Anti-Scl-70 14) Anti-Jo-1 15) Anti-Rib-P 16) Rheumatoid Factor IgA 17) Rheumatoid Factor IgG 18) Rheumatoid Factor IgM 19) Rheumatoid Factor Screen 20) Anti-Nucleosome 21) Anti-RNP-70 22) Anti-Centromere B 23) ANAscreen 24) Anti-alpha-Fodrin IgA 25) Anti-alpha-Fodrin IgG 26) Anti-MCV 27) Anti-C1q 28) Anti-SS-A 52 29) Anti-SS-A 60
Product Name: 1) ANA Detect 2) Anti-dsDNA IgA 3) Anti-dsDNA IgG 4) Anti-dsDNA IgM 5) Anti-dsDNA Screen 6) Anti-ssDNA 7) ENAscreen 8) Anti-Histone 9) Anti-SS-A 10) Anti-SS-B 11) Anti-Sm 12) Anti-RNP/Sm 13) Anti-Scl-70 14) Anti-Jo-1 15) Anti-Rib-P 16) Rheumatoid Factor IgA 17) Rheumatoid Factor IgG 18) Rheumatoid Factor IgM 19) Rheumatoid Factor Screen 20) Anti-Nucleosome 21) Anti-RNP-70 22) Anti-Centromere B 23) ANAscreen 24) Anti-alpha-Fodrin IgA 25) Anti-alpha-Fodrin IgG 26) Anti-MCV 27) Anti-C1q 28) Anti-SS-A 52 29) Anti-SS-A 60

Registration information

Registration Date: May 27, 2024
Database ID: cmhaytsdn08rmekuzd90hr1ur

Authorized representative

Name: BIOARS S.A.

Documents

Registration PDF ↗

Product information

NOT APPLICABLE

Spanish:

NO CORRESPONDE

About this record

Access comprehensive regulatory information for 1) ANA Detect 2) Anti-dsDNA IgA 3) Anti-dsDNA IgG 4) Anti-dsDNA IgM 5) Anti-dsDNA Screen 6) Anti-ssDNA 7) ENAscreen 8) Anti-Histone 9) Anti-SS-A 10) Anti-SS-B 11) Anti-Sm 12) Anti-RNP/Sm 13) Anti-Scl-70 14) Anti-Jo-1 15) Anti-Rib-P 16) Rheumatoid Factor IgA 17) Rheumatoid Factor IgG 18) Rheumatoid Factor IgM 19) Rheumatoid Factor Screen 20) Anti-Nucleosome 21) Anti-RNP-70 22) Anti-Centromere B 23) ANAscreen 24) Anti-alpha-Fodrin IgA 25) Anti-alpha-Fodrin IgG 26) Anti-MCV 27) Anti-C1q 28) Anti-SS-A 52 29) Anti-SS-A 60 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 May 27, 2024.

This page provides complete registration details including product code (1127-137), brand name (1) ANA Detect 2) Anti-dsDNA IgA 3) Anti-dsDNA IgG 4) Anti-dsDNA IgM 5) Anti-dsDNA Screen 6) Anti-ssDNA 7) ENAscreen 8) Anti-Histone 9) Anti-SS-A 10) Anti-SS-B 11) Anti-Sm 12) Anti-RNP/Sm 13) Anti-Scl-70 14) Anti-Jo-1 15) Anti-Rib-P 16) Rheumatoid Factor IgA 17) Rheumatoid Factor IgG 18) Rheumatoid Factor IgM 19) Rheumatoid Factor Screen 20) Anti-Nucleosome 21) Anti-RNP-70 22) Anti-Centromere B 23) ANAscreen 24) Anti-alpha-Fodrin IgA 25) Anti-alpha-Fodrin IgG 26) Anti-MCV 27) Anti-C1q 28) Anti-SS-A 52 29) Anti-SS-A 60), 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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