FDA.reportPublic FDA data

cobas® 4800 System Lysis Kit

Primary DI
00875197004434
Brand
cobas® 4800 System Lysis Kit
Company
Roche Molecular Systems, Inc.
Model
1.0
Catalog number
06768270190
Published
2016-09-24
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
OQOHerpes Simplex Virus Nucleic Acid Amplification Assay

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OQOHerpes Simplex Virus Nucleic Acid Amplification AssayMicrobiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197004434PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197004434008751970044348751970044340875197004434

GMDN Terms#

Term, Definition table
TermDefinition
Nucleic acid extraction/isolation kit IVDA collection of reagents and other associated materials intended to be used for the extraction and/or isolation of nucleic acid from clinical specimens and/or biological cultures in preparation for subsequent analysis using a nucleic acid-based method. Some types may include controls for the subsequent nucleic acid technique (NAT) analysis.

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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15420045507227Aptima®Hologic, Inc.OQO2017-06-23
15420045507234Aptima®Hologic, Inc.OQO2017-06-23
25420045507248Aptima®Hologic, Inc.OQO2017-02-16
04053228004660artus® HSV-1/2 QS-RGQ MDx KitQIAGEN GmbHOQO2017-01-04
00875197004458cobas® 4800 Systems Internal Control KitRoche Molecular Systems, Inc.OQO2016-09-24
00875197005264cobas® 4800 System Lysis KitRoche Molecular Systems, Inc.OQO2016-09-24
20816101025507Simplexa™ HSV 1 & 2 DirectDIASORIN MOLECULAR LLCOQO2016-09-22
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00840487101032Mutlicode®-RTx HSV 1&2 KitLUMINEX CORPORATIONOQO2016-09-09
00382904417482Control Set for the BD ProbeTec™ Herpes Simplex VirusesBECTON, DICKINSON AND COMPANYOQO2016-07-07
00382904417499BD ProbeTec™ Herpes Simplex Viruses Assays Reagent PackBECTON, DICKINSON AND COMPANYOQO2016-07-07