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BIOARS S.A. - Authorized Company Profile

Explore comprehensive authorized company profile for BIOARS S.A. through Pure Global AI's free Argentina medical device database. This company manufactures 207 medical devices registered with ANMAT across 5 registration types. Their registration history spans from Sep 19, 2018 to Aug 06, 2024.

This page provides detailed insights including recent registrations, registration type distribution (IVD Modification Group A and B: 86, Registration of products for IVD diagnostics - Group C and D: 13, IVD Registration Group A and B: 83, and more), and complete regulatory information from the official Argentina ANMAT (National Administration of Drugs, Foods and Medical Technology) medical device database with bilingual Spanish/English support. Pure Global AI offers free access to Argentina's complete medical device registry.

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207 Devices
5 Registration Types
BIOARS S.A.
Authorized Company
207
Total Devices
5
Registration Types
2018
Earliest
2024
Latest
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Recent Registrations
Latest 20 ANMAT device registrations

Chemiluminescent immunoassays (CLIA) for use in the iFlash automated analyzer for detection of respiratory disease antibodies in human serum and plasma

Inmunoensayos quimioluminiscentes (CLIA) para ser utilizados en el analizador automatizado iFlash para detecciรณn de anticuerpos de enfermedades respiratorias en suero y plasma humano

1127-387

Non-agile modification of products for IVD diagnostics - Group C and D
Aug 06, 2024

Autoantibodies RL/RK/RS

1127-37

IVD Modification Group A and B
Aug 02, 2024

REACTIVOS 1) iFlash- ACTH 2) iFlash- Cortisol 3) iFlash- PTH 4) iFlash-25-OH Vitamin D 5) iFlash-25-OH Vitamin D II 6) iFlash-17a-OH-P CONTROLES 7) ACTH Control

1127-398

IVD Modification Group A and B
Jul 31, 2024

I) REACTIVOS 1) iFlash-HCG 2) iFlash-Inhibin A 3) iFlash-Inhibin B 4) iFlash-AMH 5) iFlash-Progesterone 6) iFlash-Testosterone 7) iFlash-LH 8) iFlash-FSH 9) iFlash-Prolactin 10) iFlash-E2 11) iFlash-PAPP-A 12) iFlash-free รŸhCG 13) iFlash-Unconjugated Estriol 14) iFlash-DHEA-S II) CONTROLES 15) AMH Control 16) Inhibin B Control 17) Inhibin A Control 18) Unconjugated Estriol Control 19) free รŸhCG Control 20) PAPP-A Control

1127-386

IVD Modification Group A and B
Jul 30, 2024

ZytoLight PROBES FOR FISH TECHNIQUES (IN SITU HYBRIDIZATION WITH FLUORESCENCE)

SONDAS ZytoLight PARA TECNICAS DE FISH (HIBRIDACION IN SITU CON FLUORESCENCIA)

1127-8451

Agile modification of product registration for IVD diagnostics - Group C and D
Jul 30, 2024

1) ANAscl plus Dot 2) ANA 12 Line 3) ANA 18 Line 4) ANCA Dot 5) HepAK plus Dot 6) PmScl plus Dot 7) HepAK 7 plus Dot

1127-216

IVD Modification Group A and B
Jul 19, 2024

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

1127-385

IVD Modification Group A and B
Jul 17, 2024

I) REACTIVOS 1) iFlash-ANA 2) iFlash-dsDNA IgG 3) iFlash-Sm IgG 4) iFlash-SS-A IgG 5) iFlash-SS-B IgG 6) iFlash-RNP70 IgG 7) iFlash-Jo-1 IgG 8) iFlash-Scl-70 IgG 9) iFlash-AMA-M2 10) iFlash-SMA IgG 11) iFlash-RF IgG 12) iFlash-RF IgM 13) iFlash-RF 14) iFlash-Anti-CCP 15) iFlash-RA33 IgG II) REACTIVOS ACCESORIOS 16) Wash Buffer (1 ร—) 17) Wash Buffer (10 ร—) III) INSTRUMENTO 18) Chemiluminescence Immunoassay Analyzer IV) CONTROLES 19) ANA Control 20) dsDNA IgG Control 21) AMA-M2 Control 22) RA33 IgG Control 23) Rheumatoid Arthritis Multi Control

1127-390

IVD Modification Group A and B
Jul 15, 2024

I) REACTIVOS: 1) iFlash-Cardiolipin IgG 2) iFlash-Cardiolipin IgM 3) iFlash-Cardiolipin IgA 4) iFlash-Anti-Cardiolipin 5) iFlash-รŸ2-Glycoprotein I IgG 6) iFlash-รŸ2-Glycoprotein I IgM 7) iFlash-รŸ2-Glycoprotein I IgA 8) iFlash-Anti-รŸ2-Glycoprotein I 9) iFlash-MPO IgG 10) iFlash-PR3 IgG 11) iFlash-GBM IgG II) CONTROLES: 12) Cardiolipin IgG Control 13) Cardiolipin IgM Control 14) Cardiolipin IgA Control 15) Anti-Cardiolipin Control 16) รŸ2-Glycoprotein I IgG Control 17) รŸ2-Glycoprotein I IgM Control 18) รŸ2-Glycoprotein I IgA Control 19) Anti-รŸ2-Glycoprotein I Control 20) MPO IgG Control 21) PR3 IgG Control 22) GBM IgG Control

1127-384

IVD Modification Group A and B
Jul 12, 2024

1) Anti-Cardiolipin IgG/IgM (ORG 515) 2) Anti-Cardiolipin Screen (ORG 515S) 3) Anti-beta-2-Glycoprotein I IgA (ORG 521A) 4) Anti-beta-2-Glycoprotein I IgG/IgM (ORG 521) 5) Anti-beta-2-Glycoprotein I Screen (ORG 521S) 6) Anti-Phospholipid Screen IgG/IgM (ORG 529) 7) Anti-Phosphatidyl Serine IgG/IgM (ORG 535) 8) Anti-Phosphatidyl Inositol IgG/IgM (ORG 536) 9) Anti-Phosphatidic Acid IgG/IgM (ORG 537)

1127-443

IVD Modification Group A and B
Jul 08, 2024

1) HSV1 IgG; 2) HSV2 IgG; 3) HSV1&2 IgG.

1127-8027

Agile modification of product registration for IVD diagnostics - Group C and D
Jul 03, 2024

1) HSV1 IgM; 2) HSV2 IgM; 3) HSV1&2 IgM

1127-8041

Agile modification of product registration for IVD diagnostics - Group C and D
Jul 03, 2024

CHLAMYDIA TRACHOMATIS ELISA IgG/IgM

1127-41

Agile modification of product registration for IVD diagnostics - Group C and D
Jun 07, 2024

1) Idylla CONSOLE 2) Idylla INSTRUMENT 3) Idylla BRAF Mutation Test 4) Idylla KRAS Mutation Test

1127-8557

Agile modification of product registration for IVD diagnostics - Group C and D
Jun 06, 2024

BRUCELLA ELISA IgM

1127-54

Agile modification of product registration for IVD diagnostics - Group C and D
Jun 06, 2024

ZytoLight Probes (Sarcoma Family)

ZytoLight Sondas (Familia Sarcomas)

1127-8449

Agile modification of product registration for IVD diagnostics - Group C and D
Jun 06, 2024

A) ZytoLight PROBES; B) ACCESSORY REAGENTS

A) SONDAS ZytoLight; B) REACTIVOS ACCESORIOS

1127-8428

Agile modification of product registration for IVD diagnostics - Group C and D
Jun 06, 2024

HYDATIDOSIS ELISA IgG

1127-42

IVD Modification Group A and B
May 29, 2024

VIRAPID MONO M&G

1127-120

IVD Modification Group A and B
May 29, 2024

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

1127-137

IVD Modification Group A and B
May 27, 2024
Registration Type Distribution
Devices by registration type
IVD Modification Group A and B
86
41.5% of total
IVD Registration Group A and B
83
40.1% of total
Agile modification of product registration for IVD diagnostics - Group C and D
21
10.1% of total
Registration of products for IVD diagnostics - Group C and D
13
6.3% of total
Non-agile modification of products for IVD diagnostics - Group C and D
4
1.9% of total