FDA.reportPublic FDA data

cobas Factor II and Factor V Test

Primary DI
00875197005998
Brand
cobas Factor II and Factor V Test
Company
Roche Molecular Systems, Inc.
Model
07948352190
Catalog number
07948352190
Published
2018-02-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
NPQTEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR
NPRTEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NPQTest, Factor V Leiden Mutations, Genomic Dna PcrHematology2
NPRTest, Factor Ii G20210a Mutations, Genomic Dna PcrHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172913000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172913000cobas Factor II and Factor V TestRoche Molecular Systems, Inc.2018-01-12NPR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197005998PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197005998008751970059988751970059980875197005998

GMDN Terms#

Term, Definition table
TermDefinition
Inherited thrombophilia IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used to evaluate a clinical specimen to diagnose, monitor or predict inherited thrombophilia, which may be associated with, but not limited to, the prothrombin 20,210 mutation and/or the Factor V Leiden mutation (activated protein C resistance), using a nucleic acid technique (NAT).

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

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00840487101728Hypercoagulation Panel (HC) Sample BufferLUMINEX CORPORATIONNPQ2019-12-05
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00850009370068INFINITI® Factor II Amplification MixAUTOGENOMICS, INCNPR2019-10-23
00850009370075INFINITI® Factor V Leiden BioFilmChip® Microarray MagazineAUTOGENOMICS, INCNPQ2019-10-23
00850009370082INFINITI® Factor V Leiden Intellipac® Reagent ModuleAUTOGENOMICS, INCNPQ2019-10-23
00850009370099INFINITI® Factor V Leiden Amplification MixAUTOGENOMICS, INCNPQ2019-10-23
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00850009370112INFINITI® Factor II-V Leiden Intellipac® Reagent ModuleAUTOGENOMICS, INCNPQ2019-10-23
00850009370112INFINITI® Factor II-V Leiden Intellipac® Reagent ModuleAUTOGENOMICS, INCNPR2019-10-23
00850009370129INFINITI® Factor II-V Leiden Amplification MixAUTOGENOMICS, INCNPQ2019-10-23
00850009370129INFINITI® Factor II-V Leiden Amplification MixAUTOGENOMICS, INCNPR2019-10-23
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07332940000240Xpert Factor II & Factor VCEPHEIDNPR2018-01-29
07332940000936Xpert HemosIL FII & FVCEPHEIDNPR2018-01-29
07332940000936Xpert HemosIL FII & FVCEPHEIDNPQ2018-01-29
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00857573006348Hypercoagulation Panel (HC) Sample BufferNANOSPHERE, INC.NPR2016-09-23
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