Authorized company profile

ABBOTT RAPID DIAGNOSTICS ARGENTINA S.A.

213 devices registered with ANMAT · 5 registration types · Jul 06, 2018 – Jun 06, 2024

213

Total Devices

5

Registration Types

2018

Earliest

2024

Latest

Recent registrations

Latest 20 ANMAT device registrations

Panbio™ COVID-19/Flu A&B Panel (Nasal)

IVD Registration Group A and BJun 06, 2024

1) SoToxa™ Oral Fluid Mobile Test System 2) SoToxa™ Oral Fluid Test Kit

IVD Modification Group A and BMay 27, 2024

HBsAg Hepatitis B Surface Antigen Rapid Test Device (Whole Blood/Serum/Plasma)

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

1) Afinion™ HbA1c 2) Afinion™ HbA1c Control

IVD Modification Group A and BMay 06, 2024

Bioline™ Malaria

Registration of products for IVD diagnostics - Group C and DMay 03, 2024

FOB One Step Fecal Occult Blood Test Device (Feces)

IVD Modification Group A and BApr 16, 2024

Bioline™ Zika IgM

Agile modification of product registration for IVD diagnostics - Group C and DApr 11, 2024

Panbio™ HIV Verification Test

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

Determine™ HIV Early Detect

Non-agile modification of products for IVD diagnostics - Group C and DFeb 16, 2024

(1) The Heat Analyzer; 2) HIV 1/2 detection; 3) m-TEST HIV-1/2 VL

1) m-PIMA Analyzer; 2) m-PIMA HIV-1/2 Detect; 3) m-PIMA HIV-1/2 VL

Agile modification of product registration for IVD diagnostics - Group C and DJan 22, 2024

CheckNOW™ HIV Self Test

Registration of products for IVD diagnostics - Group C and DNov 06, 2023

Multi-Drug 7 drugs Rapid Test Cassette

IVD Registration Group A and BOct 27, 2023

1) CHOLESTECH LDX™ TC 2) CHOLESTECH LDX™ TC-HDL 3) CHOLESTECH LDX™ TC-GLU 4) CHOLESTECH LDX™ LIPID PROFILE 5) CHOLESTECH LDX™ TC-HDL-GLU 6) CHOLESTECH LDX™ LIPID PROFILE-GLU

IVD Modification Group A and BSep 05, 2023

1) CHOLESTECH LDX™ ANALYZER 2) CHOLESTECH LDX™ MINIPET PIPETTE TIPS (Ref. 11-010) 3) CHOLESTECH LDX™ MINIPET PIPETTE (Ref. 13-014) 4) CHOLESTECH LDX™ CAPILLARY PLUNGERS (Ref. 10-311) 5) CHOLESTECH LDX™ CAPILLARY TUBES (Ref. 52193) 6) CHOLESTECH LDX™ OPTICS CHECK CASSETTE (Ref. 10-228)

IVD Modification Group A and BAug 23, 2023

Cholestech LDX™ Multianalyte Control

IVD Modification Group A and BAug 23, 2023

NycoCard™ READER II

IVD Modification Group A and BAug 11, 2023

ID NOW™ COVID-19 2.0

Agile modification of product registration for IVD diagnostics - Group C and DAug 11, 2023

Syphilis Ultra Rapid Test Device (Whole Blood/Serum/ Plasma)

Registration of products for IVD diagnostics - Group C and DAug 10, 2023

One Step H.pylori Antigen Test Device (Feces)

IVD Registration Group A and BAug 03, 2023

1. ID NOW™ INFLUENZA A & B 2 2. ID NOW™ INFLUENZA A & B 2 Control Swab Kit

IVD Modification Group A and BJul 28, 2023

View All 213 Devices →

Registration type distribution

Devices by registration type

IVD Modification Group A and B

143

67.1% of total

IVD Registration Group A and B

44

20.7% of total

Agile modification of product registration for IVD diagnostics - Group C and D

13

6.1% of total

Registration of products for IVD diagnostics - Group C and D

10

4.7% of total

Non-agile modification of products for IVD diagnostics - Group C and D

3

1.4% of total

About this profile

Explore comprehensive authorized company profile for ABBOTT RAPID DIAGNOSTICS ARGENTINA S.A. through Pure Global AI's free Argentina medical device database. This company manufactures 213 medical devices registered with ANMAT across 5 registration types. Their registration history spans from Jul 06, 2018 to Jun 06, 2024.

This page provides detailed insights including recent registrations, registration type distribution (IVD Modification Group A and B: 143, Registration of products for IVD diagnostics - Group C and D: 10, IVD Registration Group A and B: 44, 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 AI213 Devices5 Registration Types