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Manufacturer profile

BIOFIRE DIAGNOSTICS, LLC

TaiwanUnited States11 products registeredSep 15, 2015 – May 09, 2023
VerifiedTFDA · Taiwan Food and Drug Administration registry
11
Total products
11
Product types
10
Active products
May 2023
Latest registration
Company details
Address
515 Colorow Dr., Salt Lake City, Utah 84108, U.S.A.
Regulatory footprint
Search BIOFIRE DIAGNOSTICS, LLC across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Recent registrations
Latest 5 products registered by this manufacturer
Multi-standard nucleic acid detection reagent set for respiratory pathogens in Bayerfa
Class 3
May 09, 2023
Second-generation reagent set for nucleic acid detection with multiple standards for the identification of blood cultures by Bayerfa
Class 2
Jan 27, 2021
Multi-standard nucleic acid detection reagent set for microcrystalline pneumonia pathogens
Class 2
Aug 27, 2020
Second-generation amplification reagent set for multi-standard nucleic acid detection of microcrystalline respiratory pathogens
Class 2
Jul 27, 2020
FilmArray Respiratory Panel 2 (RP2)
Class 2
Jan 11, 2019
Most popular products
Products with most registrations
Multi-standard nucleic acid detection reagent set for respiratory pathogens in Bayerfa
1 registrations
Second-generation reagent set for nucleic acid detection with multiple standards for the identification of blood cultures by Bayerfa
1 registrations
Multi-standard nucleic acid detection reagent set for microcrystalline pneumonia pathogens
1 registrations
Second-generation amplification reagent set for multi-standard nucleic acid detection of microcrystalline respiratory pathogens
1 registrations
FilmArray Respiratory Panel 2 (RP2)
1 registrations
Authorized representatives
Taiwan authorized representatives for this manufacturer
Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
7 products
BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)
4 products
Recent registered products
Most recent products (showing top 20)
Multi-standard nucleic acid detection reagent set for respiratory pathogens in Bayerfa
Registered: May 09, 2023 • Expires: May 09, 2028
Risk Class
Class 3
AR
BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)
Second-generation reagent set for nucleic acid detection with multiple standards for the identification of blood cultures by Bayerfa
Registered: Jan 27, 2021 • Expires: Jan 27, 2026
Risk Class
Class 2
AR
BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)
Multi-standard nucleic acid detection reagent set for microcrystalline pneumonia pathogens
Registered: Aug 27, 2020 • Expires: Aug 27, 2025
Risk Class
Class 2
AR
BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)
Second-generation amplification reagent set for multi-standard nucleic acid detection of microcrystalline respiratory pathogens
Registered: Jul 27, 2020 • Expires: Jul 27, 2025
Risk Class
Class 2
AR
BIOMERIEUX CHINA LIMITED, TAIWAN BRANCH (HONG KONG)
FilmArray Respiratory Panel 2 (RP2)
Registered: Jan 11, 2019 • Expires: Jan 11, 2024
Risk Class
Class 2
Type
MD
AR
Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
FilmArray Torch
Registered: Nov 30, 2018 • Expires: Nov 30, 2028
Risk Class
Class 2
Type
MD
AR
Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
FilmArray Meningitis/Encephalitis Panel (ME)
Registered: Mar 29, 2017 • Expires: Mar 29, 2027
Risk Class
Class 2
Type
MD
AR
Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
FilmArray Blood Culture Identification Panel (BCID)
Registered: Feb 14, 2017 • Expires: Feb 14, 2027
Risk Class
Class 2
Type
MD
AR
Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
FilmArray Gastrointestinal (GI) Panel
Registered: Dec 01, 2016 • Expires: Dec 01, 2026
Risk Class
Class 2
Type
MD
AR
Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
FilmArray Respiratory Panel (RP)
Registered: Mar 17, 2016 • Expires: Mar 17, 2021
Cancelled
Risk Class
Class 2
Type
MD
AR
Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
FilmArray 2.0 Instrument
Registered: Sep 15, 2015 • Expires: Sep 15, 2025
Risk Class
Class 2
Type
MD
AR
Hong Kong Commercial Mérieux S.p.A. Taiwan Branch
About this profile

Explore comprehensive manufacturer profile for BIOFIRE DIAGNOSTICS, LLC based in United States through Pure Global AI's free Taiwan medical device database. This manufacturer has 11 products registered in Taiwan across 11 unique product categories. Their regulatory history spans from Sep 15, 2015 to May 09, 2023.

This page provides detailed insights including 5 recent product registrations, 5 most popular products with Multi-standard nucleic acid detection reagent set for respiratory pathogens in Bayerfa having 1 registrations, and 2 authorized representatives including Hong Kong Commercial Mérieux S.p.A. Taiwan Branch. Pure Global AI offers free access to Taiwan's medical device database, enabling global MedTech companies to analyze market dynamics and identify opportunities.