FDA.reportPublic FDA data

cobas PCR Media Dual Swab Sample Kit

Primary DI
00875197005738
Brand
cobas PCR Media Dual Swab Sample Kit
Company
Roche Molecular Systems, Inc.
Model
07958021190
Catalog number
07958021190
Published
2017-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Safe
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
LIODevice, specimen collection
LSLDNA-REAGENTS, NEISSERIA
MKZDNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA
OOIreal time Nucleic acid amplification system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LIODevice, Specimen CollectionMicrobiology1
LSLDna-Reagents, NeisseriaMicrobiology2
MKZDna Probe, Nucleic Acid Amplification, ChlamydiaMicrobiology1
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00875197005738PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00875197005738008751970057388751970057380875197005738

GMDN Terms#

Term, Definition table
TermDefinition
Multiple sexually transmitted pathogen 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 multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
071674100
Device count
1
Kit
true
Combination product
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
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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
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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

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