Authorized representative profileAbbott Rapid Diagnostics Health Corp.
Taiwan臺北市松山區南京東路4段16號11樓20 products representedJan 25, 2019 – Mar 06, 2024
VerifiedTFDA · Taiwan Food and Drug Administration registry
20
Products represented
13
Manufacturers
20
Active products
Mar 2024
Latest registration
Company details
- Address
- 臺北市松山區南京東路4段16號11樓
- Authorization Code
- 4246879
Regulatory footprint
Search Abbott Rapid Diagnostics Health Corp. across other regulatory registries
Thailand
European Union
Colombia
South Korea
Canada
EcuadorRecent registrations
Latest 5 products represented by this organization
"Apei" new coronavirus antigen rapid test kit
Class 3
Mar 06, 2024
"APEP" home coronavirus antigen test kit
Class 3
Feb 27, 2024
"Aber" Brierling Respiratory Fusion Virus Antigen Diagnostic Reagent (Non-sterilized)
Class 1
Nov 21, 2023
"Abete" single-step Helicobacter pylori (fecal) antigen rapid test reagent (non-sterilized)
Class 1
Aug 22, 2023
"Coris" Adenovirus Positive Control (Non-Sterile)
Class 1
Jun 28, 2022
Most popular products
Products with most registrations
"Apei" new coronavirus antigen rapid test kit
1 registrations
"APEP" home coronavirus antigen test kit
1 registrations
"Aber" Brierling Respiratory Fusion Virus Antigen Diagnostic Reagent (Non-sterilized)
1 registrations
"Abete" single-step Helicobacter pylori (fecal) antigen rapid test reagent (non-sterilized)
1 registrations
"Coris" Adenovirus Positive Control (Non-Sterile)
1 registrations
Represented manufacturers
Manufacturers whose products are represented by this organization
Recent represented products
Most recent products (showing top 20)
"Apei" new coronavirus antigen rapid test kit
Registered: Mar 06, 2024 • Expires: Mar 06, 2029
- Risk Class
- Class 3
- Manufacturer
- Abbott Rapid Diagnostics Jena GmbH;; ABBOTT DIAGNOSTICS KOREA INC.
"APEP" home coronavirus antigen test kit
Registered: Feb 27, 2024 • Expires: Feb 27, 2029
- Risk Class
- Class 3
- Manufacturer
- Abbott Rapid Diagnostics Jena GmbH;; ABBOTT DIAGNOSTICS KOREA INC.
"Aber" Brierling Respiratory Fusion Virus Antigen Diagnostic Reagent (Non-sterilized)
Registered: Nov 21, 2023 • Expires: Nov 21, 2028
- Risk Class
- Class 1
- Manufacturer
- Abbott Diagnostics Korea Inc.
"Abete" single-step Helicobacter pylori (fecal) antigen rapid test reagent (non-sterilized)
Registered: Aug 22, 2023 • Expires: Aug 22, 2028
- Risk Class
- Class 1
- Manufacturer
- ABON BIOPHARM (HANGZHOU) CO., LTD
"Coris" Adenovirus Positive Control (Non-Sterile)
Registered: Jun 28, 2022 • Expires: Jun 28, 2027
- Risk Class
- Class 1
- Type
- MD
- Manufacturer
- CORIS BIOCONCEPT
"Abbott" drops acquired immunodeficiency virus two-in-one test strip
Registered: Oct 08, 2021 • Expires: Oct 08, 2026
- Risk Class
- Class 3
- Manufacturer
- ABBOTT DIAGNOSTICS MEDICAL CO., LTD.-CHIBA PLANT
"Dynex" Disco Clinical Use Enzyme Analyzer (Unsterilized)
Registered: Oct 01, 2021 • Expires: Oct 31, 2025
- Risk Class
- Class 1
- Manufacturer
- DYNEX TECHNOLOGIES INC.
"Dinax" Diess Clinical use enzyme analyzer (unsterilized)
Registered: Oct 01, 2021 • Expires: Oct 31, 2025
- Risk Class
- Class 1
- Manufacturer
- DYNEX TECHNOLOGIES INC.
"Gosden Dynos" Thunder Immunity Analyzer (Unsterilized)
Registered: Oct 01, 2021 • Expires: Oct 31, 2026
- Risk Class
- Class 1
- Manufacturer
- GOLD STANDARD DIAGNOSTICS CORP.
"Coris" Pylori Positive Control (Non-Sterile)
Registered: Jul 30, 2021 • Expires: Jul 30, 2026
- Risk Class
- Class 1
- Type
- MD
- Manufacturer
- CORIS BIOCONCEPT
"Abbot" drops acquired immunodeficiency virus test quality control group
Registered: May 10, 2021 • Expires: May 10, 2026
- Risk Class
- Class 2
- Manufacturer
- ABBOTT DIAGNOSTICS MEDICAL CO., LTD.-CHIBA PLANT
"Vircell" Microbiological Specimen Collection and Transport Device (Non-Sterile)
Registered: Feb 25, 2021 • Expires: Feb 25, 2026
- Risk Class
- Class 1
- Type
- MD
- Manufacturer
- VIRCELL, S.L
"Abbot" Efinin C-reactive protein assay set
Registered: Jan 08, 2021 • Expires: Jan 08, 2026
- Risk Class
- Class 2
- Manufacturer
- ABBOTT DIAGNOSTICS TECHNOLOGIES AS
"Abbot" Rapid Test Reagent for Influenza Virus Antigen
Registered: Aug 28, 2020 • Expires: Aug 28, 2025
- Risk Class
- Class 2
- Manufacturer
- ABBOTT DIAGNOSTICS KOREA INC.
"Vircell" VARICELLA-ZOSTER ELISA IgG/IgM
Registered: Mar 17, 2020 • Expires: Mar 17, 2025
- Risk Class
- Class 2
- Type
- MD
- Manufacturer
- VIRCELL, S.L
BinaxNOW Influenza A & B Card 2
Registered: Mar 02, 2020 • Expires: Mar 02, 2025
- Risk Class
- Class 2
- Type
- MD
- Manufacturer
- Abbott Diagnostics Scarborough, Inc.
"Abbot" Efinin second generation analyzer
Registered: Jan 02, 2020 • Expires: Jan 02, 2030
- Risk Class
- Class 2
- Manufacturer
- Abbott Diagnostics Technologies AS
"Abbott" Alere NT-proBNP for Alinity i Reagent Kit
Registered: Dec 26, 2019 • Expires: Dec 26, 2024
- Risk Class
- Class 2
- Type
- MD
- Manufacturer
- Axis-Shield Diagnostics Limited
“Vircell” HERPES SIMPLEX 1 VIRCLIA IgG MONOTEST
Registered: Feb 13, 2019 • Expires: Feb 13, 2024
- Risk Class
- Class 2
- Type
- MD
- Manufacturer
- VIRCELL, S.L
“Vircell” CYTOMEGALOVIRUS VIRCLIA IgM MONOTEST
Registered: Jan 25, 2019 • Expires: Jan 25, 2024
- Risk Class
- Class 2
- Type
- MD
- Manufacturer
- VIRCELL, S.L
About this profile
Explore comprehensive authorized representative profile for Abbott Rapid Diagnostics Health Corp. through Pure Global AI's free Taiwan medical device database. This authorized representative handles 20 product registrations across 13 manufacturers and 20 unique product types. Their regulatory history spans from Jan 25, 2019 to Mar 06, 2024.
This page provides detailed insights including 5 recent product registrations, 5 most popular products with "Apei" new coronavirus antigen rapid test kit having 1 registrations, and 5 represented manufacturers including VIRCELL, S.L. Pure Global AI offers free access to Taiwan's medical device database, enabling global MedTech companies to analyze market dynamics and identify opportunities.