FDA.reportPublic FDA data

cobas&#x00AE EBV/BKV Control Kit

Primary DI
00875197006254
Brand
cobas&#x00AE EBV/BKV Control Kit
Company
Roche Molecular Systems, Inc.
Model
08688214190
Catalog number
08688214190
Published
2020-09-10
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
CodeName
QLXNucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QLXNucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) DnaMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197006254PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197006254008751970062548751970062540875197006254

GMDN Terms#

Term, Definition table
TermDefinition
Multiple immunocompromised host infection-associated virus nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from one or multiple viruses associated with infection of the immunocompromised host, which may include Epstein-Barr virus (EBV), human cytomegalovirus (CMV) and BK virus (BKV) in a clinical specimen.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071674100
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 DIBrandModelCatalogPublished
07613336231098Opulus Lymphoma Precision10257873001102578730012026-05-08
00875197006476cobas® HBV/HCV/HIV-1 Control Kit09040773190090407731902021-12-10
00875197004014cobas® TaqScreen MPX Control Kit, v2.02.0059653901902015-02-20
00875197001068COBAS® AmpliScreen HCV Test, v2.02033025630182014-09-17
00875197001099COBAS® AmpliScreen HIV-1 Test, v1.52033221140182014-09-09
00875197001662cobas® TaqScreen MPX Test04584252190045842521902014-09-17
00875197002102COBAS® AmpliScreen HBV Test03599779190035997791902014-09-17
00875197004045cobas® TaqScreen MPX Test, v2.02.0059694841902015-02-20
07613336206355cobas® 6800 system09575154001095751540012026-03-26
07613336206362cobas® 8800 system09575146001095751460012026-03-26
00875197007459cobas® Liat Transfer Pipette Pack10383852190103838521902026-03-26
00875197005240cobas® Cdiff Test06768237190067682371902026-02-24
00875197005288cobas® 4800 Cdiff Controls and Cofactor Kit06768300190067683001902026-02-24
00875197006056cobas® TV/MG08017450190080174501902026-02-24
00875197006063cobas® TV/MG Positive Control Kit07948689190079486891902026-02-24
00875197006377cobas® SARS-CoV-2 & Influenza A/B Quality Control Kit09211128190092111281902026-02-24
00875197006742cobas SARS-CoV-209408592190094085921902026-02-24
00875197006759cobas SARS-CoV-2 Quality Control Kit09408835190094088351902026-02-24
00875197006902cobas® TV/MG09040633190090406331902026-02-24
00875197006919cobas® TV/MG Positive Control Kit09040641190090406411902026-02-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884999051300Alinity mABBOTT MOLECULAR INC.QLX2024-01-31
00884999049482Alinity mABBOTT MOLECULAR INC.QLX2022-08-29
00884999049499Alinity mABBOTT MOLECULAR INC.QLX2022-08-29
00884999049505Alinity mABBOTT MOLECULAR INC.QLX2022-08-29
00884999049697Alinity mABBOTT MOLECULAR INC.QLX2022-08-29
00875197006278cobas&#x00AE BKVRoche Molecular Systems, Inc.QLX2020-09-30
00875197006261cobas&#x00AE EBVRoche Molecular Systems, Inc.QLX2020-09-10