FDA.reportPublic FDA data

cobas® Strep A Nucleic acid test for use on the cobas® Liat® System

Primary DI
00875197005622
Brand
cobas® Strep A Nucleic acid test for use on the cobas® Liat® System
Company
Roche Molecular Systems, Inc.
Model
07341911190
Catalog number
07341911190
Published
2016-09-24
Public version status
Update
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
PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PGXGroups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification SystemMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197005622PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197005622008751970056228751970056220875197005622

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus 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 Group A beta-haemolytic Streptococcus bacteria in a clinical specimen, 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
Serial number
true
Expiration date on label
true

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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
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07613336206362cobas® 8800 system09575146001095751460012026-03-26
00875197007459cobas® Liat Transfer Pipette Pack10383852190103838521902026-03-26
00875197005240cobas® Cdiff Test06768237190067682371902026-02-24
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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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Primary DI, Brand, Company table
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00840733102325Revogene Strep AMERIDIAN BIOSCIENCE, INC.PGX2020-07-15
00628055344179Revogene® Strep AMeridian Bioscience Canada IncPGX2019-10-21
00628055344087GenePOC™ Strep AGenePoc IncPGX2019-04-30
10811877010552ID NOW Strep A 2Alere Scarborough, Inc.PGX2018-10-29
10811877010583ID NOW Strep A 2 Control Swab KitAlere Scarborough, Inc.PGX2018-10-29
30014613336136SolanaDIAGNOSTIC HYBRIDS, INC.PGX2018-07-23
07332940002503Xpert Xpress Strep ACEPHEIDPGX2018-06-29
10811877010040Alere i Strep A 2Alere Scarborough, Inc.PGX2018-06-28
10811877010200Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.PGX2018-06-28
07332940006372Xpert Xpress Strep ACEPHEIDPGX2018-01-29
07613336156544cobas Liat Strep A Script Version 1.27Roche Molecular Systems, Inc.PGX2017-11-17
00840487101469ARIES® Group A Strep AssayLUMINEX CORPORATIONPGX2017-11-07
07613336129692cobas® Liat® Strep A ScriptRoche Molecular Systems, Inc.PGX2016-09-24
00875197005646cobas® Strep A Quality Control Kit for use on the cobas® Liat® SystemRoche Molecular Systems, Inc.PGX2016-09-24
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20816101025576Simplexa™ Group A Strep Positive Control PackDIASORIN MOLECULAR LLCPGX2016-09-22
30014613311126LyraQUIDEL CORPORATIONPGX2016-09-15
30014613312123AmpliVueQUIDEL CORPORATIONPGX2016-09-15
30014613336082SolanaQUIDEL CORPORATIONPGX2016-09-15
10811877010859Alere™ i Strep AAlere Scarborough, Inc.PGX2016-09-03
10811877010866Alere™ i Strep A Control Swab KitAlere Scarborough, Inc.PGX2016-09-03