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WIENER Laboratories S.A.I.C. - Authorized Company ProfileWIENER Laboratorios S.A.I.C.

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.

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108 Devices
4 Registration Types
WIENER Laboratories S.A.I.C.
WIENER Laboratorios S.A.I.C.
Authorized Company
108
Total Devices
4
Registration Types
2018
Earliest
2024
Latest
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Recent Registrations
Latest 20 ANMAT device registrations

WGene DENV RT Detection

1102-242

IVD Registration Group A and B
Jun 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 D
Jun 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 D
Jun 07, 2024

Chemiluminescent immunoassay (CLIA) for the quantitative determination of tumour markers

Inmunoensayo quimioluminiscente (CLIA) para la determinaci贸n cuantitativa de marcadores tumorales

1102-231

Registration of products for IVD diagnostics - Group C and D
Jun 07, 2024

1) Interleukin-6 (CLIA) 2) IL-6 Calibrators 3) IL-6 Control

1102-238

IVD Registration Group A and B
Jun 06, 2024

WGene C. trachomatis RT Detection

1102-235

Registration of products for IVD diagnostics - Group C and D
May 13, 2024

1) Anti-Mullerian Hormone (CLIA) 2) AMH Control

1102-233

IVD Registration Group A and B
May 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 B
May 02, 2024

1) Reverse Triiodothyronine (CLIA) 2) rT3 Calibrator 3) rT3 Control

1102-236

IVD Registration Group A and B
May 02, 2024

Chemiluminescent immunoassay for simultaneous detection of HIV p24 antigen and HIV-1 or HIV-2 antibodies

Inmunoensayo quimioluminiscente para la detecci贸n simult谩nea del ant铆geno p24 del HIV y los anticuerpos del HIV-1 o HIV-2

1102-171

Registration of products for IVD diagnostics - Group C and D
Apr 29, 2024

WL Check SARS-CoV-2 Ag Selftesting

1102-219

Agile modification of product registration for IVD diagnostics - Group C and D
Mar 14, 2024

ISE Reagent Pack

1102-241

IVD Registration Group A and B
Feb 05, 2024

1) ISE Cleanng Solution 2) ISE Detergent 3) Na Cleaning Solution 4) Urine Diluent

1102-239

IVD Registration Group A and B
Jan 31, 2024

1) CM Series Reagent Module LT 2) ISE Reagent Module

1102-240

IVD Registration Group A and B
Jan 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 B
Jan 10, 2024

Chemiluminescent immunoassay for the detection of hepatitis B surface antigen (HBsAg).

Inmunoensayo quimioluminiscente para la detecci贸n del ant铆geno de superficie de la hepatitis B (HBsAg).

1102-166

Registration of products for IVD diagnostics - Group C and D
Dec 21, 2023

Chemiluminescent immunoassay for the detection of hepatitis B surface antigen antibody (anti-HBs).

Inmunoensayo quimioluminiscente para la detecci贸n del anticuerpo contra el ant铆geno de superficie de la hepatitis B (anti-HBs).

1102-167

Registration of products for IVD diagnostics - Group C and D
Dec 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 B
Oct 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 B
Oct 04, 2023

Rapid test for the qualitative detection of antibodies against Treponema pallidum

Prueba r谩pida para la detecci贸n cualitativa de anticuerpos contra Treponema pallidum

1102-224

Registration of products for IVD diagnostics - Group C and D
Jul 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