Home GUDID 00884999047822 Alinity m
Primary DI 00884999047822
Brand Alinity m
Company ABBOTT MOLECULAR INC.
Model 08N50-075
Catalog number 08N50-075
Device description Alinity m HCV CAL Kit
Published 2020-05-04
Public version status New
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Single use true Product Codes# Code, Name table Code Name MZP Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class MZP Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus Microbiology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00884999047822 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00884999047822 00884999047822 884999047822 0884999047822
GMDN Terms# Term, Definition table Term Definition Hepatitis C virus nucleic acid IVD, calibrator A material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of Hepatitis C virus nucleic acid in a clinical specimen.
Storage And Handling# Type, Low, High table Type Low High Condition Storage Environment Temperature -25 Degrees Celsius -15 Degrees Celsius
Regulatory Flags# DUNS number 878263359 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 00884999050860 Alinity m ABBOTT MOLECULAR INC. MZP 2023-08-18 00875197006391 cobas® HCV Roche Molecular Systems, Inc. MZP 2021-12-10 00884999047761 Alinity m ABBOTT MOLECULAR INC. MZP 2020-05-04 00884999047839 Alinity m ABBOTT MOLECULAR INC. MZP 2020-05-04 00884999048652 Alinity m ABBOTT MOLECULAR INC. MZP 2020-05-04 00884999037472 RealTime ABBOTT MOLECULAR INC. MZP 2017-12-15 04015630935390 cobas 8800 System Roche Diagnostics GmbH MZP 2017-04-20 04015630935406 cobas 6800 System Roche Diagnostics GmbH MZP 2017-04-20 15420045506787 Aptima® Hologic, Inc. MZP 2017-03-08 15420045506794 Aptima® Hologic, Inc. MZP 2017-03-08 15420045506800 Aptima® Hologic, Inc. MZP 2017-03-08 00884999042681 RealTime ABBOTT MOLECULAR INC. MZP 2016-07-28 00875197004472 cobas omni Wash Reagent WASH) Roche Diagnostics GmbH MZP 2015-12-04 00875197004489 cobas omni Specimen Diluent SPEC DIL) Roche Diagnostics GmbH MZP 2015-12-04 00875197004496 cobas omni Lysis Reagent LYS) Roche Diagnostics GmbH MZP 2015-12-04 00875197004502 cobas omni MGP Reagent MGP) Roche Diagnostics GmbH MZP 2015-12-04 00875197004694 cobas® HCV Quantitative nucleic acid test for use on the cobas® 6800/8800 System Roche Diagnostics GmbH MZP 2015-12-04 00875197004748 cobas® HBV/HCV/HIV-1 Control Kit Roche Diagnostics GmbH MZP 2015-12-04 00875197005127 cobas® NHP Negative Control Kit Roche Diagnostics GmbH MZP 2015-12-04 00884999000698 RealTime ABBOTT MOLECULAR INC. MZP 2014-12-01 00884999000704 RealTime ABBOTT MOLECULAR INC. MZP 2014-11-20 00884999000711 RealTime ABBOTT MOLECULAR INC. MZP 2014-11-20 00884999000728 RealTime ABBOTT MOLECULAR INC. MZP 2014-11-20 00884999037434 RealTime ABBOTT MOLECULAR INC. MZP 2014-11-20 00884999037656 RealTime ABBOTT MOLECULAR INC. MZP 2014-11-20 00630414472386 VERSANT® HCV RNA 3.0 ASSAY bDNA Siemens Healthcare Diagnostics Inc. MZP 2014-09-24 00630414472393 VERSANT® HCV RNA 3.0 ASSAY bDNA Siemens Healthcare Diagnostics Inc. MZP 2014-09-24 00875197004182 COBAS® TaqMan® HCV Test For Use With the High Pure System Roche Molecular Systems, Inc. MZP 2014-09-10 00875197001983 COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test Roche Molecular Systems, Inc. MZP 2014-09-09 00875197003611 COBAS® AmpliPrep / COBAS® TaqMan® HCV Test, v2.0 Roche Molecular Systems, Inc. MZP 2014-09-09
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