Home GUDID 07332940008581 GeneXpert®
Primary DI 07332940008581
Brand GeneXpert®
Company CEPHEID
Model XPRS-COV2-10
Catalog number XPRS-COV2-10
Device description Xpert® Xpress CoV-2 plus
Published 2024-01-22
Public version status New
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 QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QQX Respiratory Specimen Nucleic Acid Sars-Cov-2 Test Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 07332940008581 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, EAN-13 table Source identifier GTIN-14 normalized EAN-13 07332940008581 07332940008581 7332940008581
GMDN Terms# Term, Definition table Term Definition SARS-CoV-2 nucleic acid IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) in a clinical specimen, using a nucleic acid technique (NAT). This test is used to aid the diagnosis of coronavirus disease (COVID-19) infection.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature 2 Degrees Celsius 28 Degrees Celsius
Regulatory Flags# DUNS number 956711444 Device count 1 Kit true Lot or batch true Expiration date on label true Other Devices From This Company# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 20816101027136 Simplexa COVID-19 Positive Control GEN II Pack DIASORIN MOLECULAR LLC QQX 2025-09-17 15420045516991 Aptima® Hologic, Inc. QQX 2025-03-14 15420045517004 Aptima® Hologic, Inc. QQX 2025-03-14 15420045517035 Aptima® Hologic, Inc. QQX 2025-03-14 10190302019439 Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer LIFE TECHNOLOGIES CORPORATION QQX 2025-02-17 10190302019422 Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Assay Kit LIFE TECHNOLOGIES CORPORATION QQX 2025-02-17 80190302019438 Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control Dilution Buffer LIFE TECHNOLOGIES CORPORATION QQX 2025-02-17 10190302019446 Applied Biosystems™ TaqPath™ COVID-19 Diagnostic PCR Control LIFE TECHNOLOGIES CORPORATION QQX 2025-02-17 00382904453619 BD Respiratory Viral Panel-SCV2 for BD MAX™ System BECTON, DICKINSON AND COMPANY QQX 2023-12-09 00382904453732 BD Respiratory Viral Panel for BD MAX™ System BECTON, DICKINSON AND COMPANY QQX 2023-09-28 00875197006841 cobas® SARS-CoV-2 Qualitative 192T Roche Molecular Systems, Inc. QQX 2023-09-12 00875197006858 cobas® SARS-CoV-2 Qualitative Control Kit Roche Molecular Systems, Inc. QQX 2023-09-12 00875197006933 cobas® SARS-CoV-2 Qualitative 480T Roche Molecular Systems, Inc. QQX 2023-09-12 20816101027020 Simplexa COVID-19 Direct DIASORIN MOLECULAR LLC QQX 2023-06-16 20816101027037 Simplexa COVID-19 Positive Control Pack DIASORIN MOLECULAR LLC QQX 2023-06-16 00851458005228 BioFire® COVID-19 Test 2 BIOFIRE DEFENSE, LLC QQX 2023-02-16 00851458005235 BioFire® COVID-19 Test 2 BIOFIRE DEFENSE, LLC QQX 2023-02-16 06973342000530 COVID-19 Coronavirus Real Time PCR Kit Jiangsu Bioperfectus Technologies Co., Ltd. QQX 2023-02-02 06973342000158 COVID-19 Coronavirus Real Time PCR Kit Jiangsu Bioperfectus Technologies Co., Ltd. QQX 2023-01-30 10789594001002 Microbrush YOUNG MICROBRUSH, LLC QQX 2022-08-16 10789594001088 Microbrush YOUNG MICROBRUSH, LLC QQX 2022-08-16 10789594001095 Microbrush YOUNG MICROBRUSH, LLC QQX 2022-08-16 10789594001101 Microbrush YOUNG MICROBRUSH, LLC QQX 2022-08-16 10789594001354 Microbrush YOUNG MICROBRUSH, LLC QQX 2022-08-16 10789594001361 Microbrush YOUNG MICROBRUSH, LLC QQX 2022-08-16 10789594001378 Microbrush YOUNG MICROBRUSH, LLC QQX 2022-08-16
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