FDA.reportPublic FDA data

cobas&#x00AE vivoDx MRSA Control Media

Primary DI
00875197005820
Brand
cobas&#x00AE vivoDx MRSA Control Media
Company
Roche Molecular Systems, Inc.
Model
08064768190
Catalog number
08064768190
Published
2020-01-15
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
QIVCulture-based short-term incubation antimicrobial resistance assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QIVCulture-Based Short-Term Incubation Antimicrobial Resistance AssayMicrobiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN190016000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN190016000cobas vivoDx MRSARoche Molecular Systems, Inc.2019-12-05QIV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197005820PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197005820008751970058208751970058200875197005820

GMDN Terms#

Term, Definition table
TermDefinition
MRSA phenotype detection IVD, kit, bioassayA collection of reagents and other associated materials intended to be used for the phenotypic detection of methicillin-resistant Staphylococcus aureus (MRSA) in live bacteria present in a clinical specimen and/or culture isolate, using a bioassay method.

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
00875197005813cobas&#x00AE vivoDx MRSA Collection and Transport KitRoche Molecular Systems, Inc.QIV2020-01-15
00875197006193cobas&#x00AE vivoDx MRSARoche Molecular Systems, Inc.QIV2020-01-15
07613336129487cobas&#x00AE vivoDx SystemRoche Molecular Systems, Inc.QIV2020-01-15