Home GUDID M70880080720 T2Bacteria® Reagent Trays
Primary DI M70880080720
Brand T2Bacteria® Reagent Trays
Company T2 BIOSYSTEMS, INC.
Model 80-08072
Device description The T2Bacteria component that contains the refrigerated reagents used to perform the T2Bacteria Panel.
Published 2024-02-20
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
OTC false
Sterile false
Single use true Product Codes# Code, Name table Code Name QBX Direct Blood Bacterial Nucleic Acid Detection System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QBX Direct Blood Bacterial Nucleic Acid Detection System Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M70880080723 Primary HIBCC 0 M70880080720 Unit of Use HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multiple-type bloodstream pathogen nucleic acid IVD, reagent A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of microorganisms associated with bloodstream infection (i.e., bacteria, fungi, and viruses) in a clinical specimen and/or culture isolate.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 8 Degrees Celsius
Regulatory Flags# DUNS number 803126320 Device count 12 DM exempt false Premarket exempt false HCT/P false Kit false Combination product false Lot or batch true Serial number false Manufacturing date on label false Expiration date on label true Donation ID number false Contains natural rubber latex false No natural rubber latex false Sterilization required before use false Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M70870049330 T2Dx® 70-04933 2017-02-12 M70890078170 T2Candida® 1.1 Cartridge Kit 90-07817 2018-06-25 M70880016893 T2Candida® Reagent Trays 80-01689 2017-02-12 M70890017940 T2Candida® Cartridge Kit 90-01794 2017-02-12 M70880080723 T2Bacteria® Reagent Trays 80-08072 2024-02-20 M70885080730 T2Bacteria® QCheck Positive Kit 85-08073 2024-02-20 M70885080743 T2Bacteria® QCheck Negative Kit 85-08074 2018-08-02 M70890080710 T2Bacteria® Cartridge Kit 90-08071 2018-08-02 M70880113943 T2Biothreat® Reagent Trays 80-11394 2023-11-07 M70885113963 T2Biothreat® QCheck Positive Kit 85-11396 2023-11-07 M70885113983 T2Biothreat® QCheck Negative Kit 85-11398 2023-11-07 M70890114000 T2Biothreat® Cartridge Kit 90-11400 2023-11-07 M70880113930 T2Biothreat® Reagent Trays 80-11394 2023-11-07 M70883113950 T2Biothreat® QCheck Positive Kit 85-11396 2023-11-07 M70883113970 T2Biothreat® QCheck Negative Kit 85-11398 2023-11-07 M70880073423 T2Bacteria® Reagent Trays 80-07342 2018-08-02 M70885083763 T2Dx® QCheck Negative Kit 85-08376 2020-02-18 M70885083760 T2Dx® QCheck Negative Kit 85-08376 2018-06-25 M70885071910 T2Bacteria® QCheck Positive Kit 85-07191 2018-08-02 M70885083750 T2Candida® QCheck Positive Kit 85-08375 2018-06-25
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published M70880080723 T2Bacteria® Reagent Trays T2 BIOSYSTEMS, INC. QBX 2024-02-20 M70885080730 T2Bacteria® QCheck Positive Kit T2 BIOSYSTEMS, INC. QBX 2024-02-20 M70880113943 T2Biothreat® Reagent Trays T2 BIOSYSTEMS, INC. QBX 2023-11-07 M70885113963 T2Biothreat® QCheck Positive Kit T2 BIOSYSTEMS, INC. QBX 2023-11-07 M70885113983 T2Biothreat® QCheck Negative Kit T2 BIOSYSTEMS, INC. QBX 2023-11-07 M70890114000 T2Biothreat® Cartridge Kit T2 BIOSYSTEMS, INC. QBX 2023-11-07 M70885071910 T2Bacteria® QCheck Positive Kit T2 BIOSYSTEMS, INC. QBX 2018-08-02 M70885080743 T2Bacteria® QCheck Negative Kit T2 BIOSYSTEMS, INC. QBX 2018-08-02 M70880073423 T2Bacteria® Reagent Trays T2 BIOSYSTEMS, INC. QBX 2018-08-02 M70890080710 T2Bacteria® Cartridge Kit T2 BIOSYSTEMS, INC. QBX 2018-08-02
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