Authorized company profileBIOARS S.A.
207 devices registered with ANMAT · 5 registration types · Sep 19, 2018 – Aug 06, 2024
207
Total Devices
5
Registration Types
2018
Earliest
2024
Latest
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 detección de anticuerpos de enfermedades respiratorias en suero y plasma humano
1127-387
Non-agile modification of products for IVD diagnostics - Group C and DAug 06, 2024
Autoantibodies RL/RK/RS
1127-37
IVD Modification Group A and BAug 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 BJul 31, 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 DJul 30, 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 ßhCG
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 ßhCG Control
20) PAPP-A Control
1127-386
IVD Modification Group A and BJul 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 BJul 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 BJul 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 ×)
17) Wash Buffer (10 ×)
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 BJul 15, 2024
I) REACTIVOS:
1) iFlash-Cardiolipin IgG
2) iFlash-Cardiolipin IgM
3) iFlash-Cardiolipin IgA
4) iFlash-Anti-Cardiolipin
5) iFlash-ß2-Glycoprotein I IgG
6) iFlash-ß2-Glycoprotein I IgM
7) iFlash-ß2-Glycoprotein I IgA
8) iFlash-Anti-ß2-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) ß2-Glycoprotein I IgG Control
17) ß2-Glycoprotein I IgM Control
18) ß2-Glycoprotein I IgA Control
19) Anti-ß2-Glycoprotein I Control
20) MPO IgG Control
21) PR3 IgG Control
22) GBM IgG Control
1127-384
IVD Modification Group A and BJul 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 BJul 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 DJul 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 DJul 03, 2024
CHLAMYDIA TRACHOMATIS ELISA IgG/IgM
1127-41
Agile modification of product registration for IVD diagnostics - Group C and DJun 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 DJun 06, 2024
BRUCELLA ELISA IgM
1127-54
Agile modification of product registration for IVD diagnostics - Group C and DJun 06, 2024
ZytoLight Probes (Sarcoma Family)
ZytoLight Sondas (Familia Sarcomas)
1127-8449
Agile modification of product registration for IVD diagnostics - Group C and DJun 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 DJun 06, 2024
HYDATIDOSIS ELISA IgG
1127-42
IVD Modification Group A and BMay 29, 2024
VIRAPID MONO M&G
1127-120
IVD Modification Group A and BMay 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 BMay 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
About this 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.
Free Authorized Company ProfilePowered by Pure Global AI207 Devices5 Registration Types