cobas HPV Positive Control 07460171190

GUDID 00875197005769

Roche Molecular Systems, Inc.

Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT) Human papillomavirus (HPV) high risk strain nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00875197005769
NIH Device Record Key745f5d83-3e1a-4574-bf64-09045bb4fd2d
Commercial Distribution StatusIn Commercial Distribution
Brand Namecobas HPV Positive Control
Version Model Number07460171190
Catalog Number07460171190
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100875197005769 [Primary]

FDA Product Code

MAQKit, Dna Detection, Human Papillomavirus

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-14
Device Publish Date2021-06-04

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