cobas¿ PCR Urine Sample Kit 05170486190

GUDID 00875197002898

Roche Molecular Systems, Inc.

Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, point-of-care Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical Sexually transmitted infection (STI) testing specimen collection kit IVD, clinical
Primary Device ID00875197002898
NIH Device Record Keyfc936d82-e227-4012-80bf-f969a54037b3
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas¿ PCR Urine Sample Kit
Version Model Number1.0
Catalog Number05170486190
Company DUNS071674100
Company NameRoche Molecular Systems, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100875197002898 [Primary]

FDA Product Code

LSLDNA-REAGENTS, NEISSERIA

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-08-09
Device Publish Date2016-03-31

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