Home GUDID M70890078170 T2Candida® 1.1 Cartridge Kit
Primary DI M70890078170
Brand T2Candida® 1.1 Cartridge Kit
Company T2 BIOSYSTEMS, INC.
Model 90-07817
Device description The T2Candida 1.1 Cartridge components used to load the patient sample, contains disposables, and the lysis reagent to perform the T2Candida panel.
Published 2018-06-25
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name PII Candida Species Nucleic Acid Detection System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class PII Candida Species Nucleic Acid Detection System Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M70890078170 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Multiple Candida species nucleic acid IVD, reagent A substance or reactant intended to be used together with other IVDs to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of nucleic acid from multiple species of the yeast Candida in a clinical specimen. Candida species intended to be detected may include Candida albicans, Candida dubliniensis, Candida glabrata, Candida kefyr, Candida krusei, Candida parapsilosis and/or Candida tropicalis.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 15 Degrees Celsius 30 Degrees Celsius
Regulatory Flags# DUNS number 803126320 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 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 M70880080720 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 M70870049330 T2Dx® 70-04933 2017-02-12 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 M70885083763 T2Dx® QCheck Negative Kit T2 BIOSYSTEMS, INC. PII 2020-02-18 M70885083750 T2Candida® QCheck Positive Kit T2 BIOSYSTEMS, INC. PII 2018-06-25 M70885083760 T2Dx® QCheck Negative Kit T2 BIOSYSTEMS, INC. PII 2018-06-25 M70885049190 T2Candida® External Controls T2 BIOSYSTEMS, INC. PII 2017-02-12 M70880016893 T2Candida® Reagent Trays T2 BIOSYSTEMS, INC. PII 2017-02-12 M70890017940 T2Candida® Cartridge Kit T2 BIOSYSTEMS, INC. PII 2017-02-12
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