Authorized company profileWIENER Laboratories S.A.I.C.
WIENER Laboratorios S.A.I.C.
108 devices registered with ANMAT · 4 registration types · Jul 02, 2018 – Jun 18, 2024
108
Total Devices
4
Registration Types
2018
Earliest
2024
Latest
Recent registrations
Latest 20 ANMAT device registrations
WGene DENV RT Detection
1102-242
IVD Registration Group A and BJun 18, 2024
1) Antibody to Hepatitis B Surface Antigen (CLIA); 2) Anti-HBs Positive Control; 3) Anti-HBs Negative Control; 4) Anti-HBs Calibrators
1102-167
Agile modification of product registration for IVD diagnostics - Group C and DJun 07, 2024
1) Hepatitis B Surface Antigen (CLIA); 2) HBsAg Positive Control; 3) HBsAg Negative Control; 4) HBsAg Calibrators
1102-166
Agile modification of product registration for IVD diagnostics - Group C and DJun 07, 2024
Chemiluminescent immunoassay (CLIA) for the quantitative determination of tumour markers
Inmunoensayo quimioluminiscente (CLIA) para la determinación cuantitativa de marcadores tumorales
1102-231
Registration of products for IVD diagnostics - Group C and DJun 07, 2024
1) Interleukin-6 (CLIA)
2) IL-6 Calibrators
3) IL-6 Control
1102-238
IVD Registration Group A and BJun 06, 2024
WGene C. trachomatis RT Detection
1102-235
Registration of products for IVD diagnostics - Group C and DMay 13, 2024
1) Anti-Mullerian Hormone (CLIA)
2) AMH Control
1102-233
IVD Registration Group A and BMay 06, 2024
1) Aldosterone (CLIA)
2) ALD Calibrators
3) Renin (CLIA)
4) Renin Calibrators
5) Hypertension Multi Control
6) Neutralization Buffer
1102-237
IVD Registration Group A and BMay 02, 2024
1) Reverse Triiodothyronine (CLIA)
2) rT3 Calibrator
3) rT3 Control
1102-236
IVD Registration Group A and BMay 02, 2024
Chemiluminescent immunoassay for simultaneous detection of HIV p24 antigen and HIV-1 or HIV-2 antibodies
Inmunoensayo quimioluminiscente para la detección simultánea del antígeno p24 del HIV y los anticuerpos del HIV-1 o HIV-2
1102-171
Registration of products for IVD diagnostics - Group C and DApr 29, 2024
WL Check SARS-CoV-2 Ag Selftesting
1102-219
Agile modification of product registration for IVD diagnostics - Group C and DMar 14, 2024
ISE Reagent Pack
1102-241
IVD Registration Group A and BFeb 05, 2024
1) ISE Cleanng Solution
2) ISE Detergent
3) Na Cleaning Solution
4) Urine Diluent
1102-239
IVD Registration Group A and BJan 31, 2024
1) CM Series Reagent Module LT
2) ISE Reagent Module
1102-240
IVD Registration Group A and BJan 31, 2024
1) Wiener lab. CMD 600
2) Wiener lab. CMD 600i
3) Wiener lab. CMD 600 X1
4) Wiener lab. CMD 600i X1
1102-160
IVD Modification Group A and BJan 10, 2024
Chemiluminescent immunoassay for the detection of hepatitis B surface antigen (HBsAg).
Inmunoensayo quimioluminiscente para la detección del antígeno de superficie de la hepatitis B (HBsAg).
1102-166
Registration of products for IVD diagnostics - Group C and DDec 21, 2023
Chemiluminescent immunoassay for the detection of hepatitis B surface antigen antibody (anti-HBs).
Inmunoensayo quimioluminiscente para la detección del anticuerpo contra el antígeno de superficie de la hepatitis B (anti-HBs).
1102-167
Registration of products for IVD diagnostics - Group C and DDec 19, 2023
1) Counter 31 AL
2) WL-31 LEO (I) Lyse
3) WL-31 LEO (II) Lyse
4) WL-31 LH Lyse
5) WL-31D Diluent
1102-179
IVD Modification Group A and BOct 05, 2023
1) Counter 29
2) Probe Cleanser
3) WL-29D Diluent
4) WL-29DIFF Lysis
5) WL-29LH Lysis
1) Counter 29
2) Probe Cleanser
3) WL-29D Diluent
4) WL-29DIFF Lyse
5) WL-29LH Lyse
1102-178
IVD Modification Group A and BOct 04, 2023
Rapid test for the qualitative detection of antibodies against Treponema pallidum
Prueba rápida para la detección cualitativa de anticuerpos contra Treponema pallidum
1102-224
Registration of products for IVD diagnostics - Group C and DJul 20, 2023
Registration type distribution
Devices by registration type
IVD Modification Group A and B
54
50.0% of total
IVD Registration Group A and B
37
34.3% of total
Registration of products for IVD diagnostics - Group C and D
12
11.1% of total
Agile modification of product registration for IVD diagnostics - Group C and D
5
4.6% of total
About this profile
Explore comprehensive authorized company profile for WIENER Laboratories S.A.I.C. through Pure Global AI's free Argentina medical device database. This company manufactures 108 medical devices registered with ANMAT across 4 registration types. Their registration history spans from Jul 02, 2018 to Jun 18, 2024.
This page provides detailed insights including recent registrations, registration type distribution (IVD Modification Group A and B: 54, IVD Registration Group A and B: 37, Registration of products for IVD diagnostics - Group C and D: 12, 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 AI108 Devices4 Registration Types