PreciControl Release Anti-HCV 09366652190

GUDID 07613336182970

Roche Diagnostics GmbH

Hepatitis C virus total antibody IVD, control
Primary Device ID07613336182970
NIH Device Record Key25643236-7f48-44a8-aced-930bc891b006
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreciControl Release Anti-HCV
Version Model Number09366652190
Catalog Number09366652190
Company DUNS315028860
Company NameRoche Diagnostics GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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 Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336182970 [Primary]

FDA Product Code

QHMSerology tests used for infectious disease screening of blood and plasma donations

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-02-26
Device Publish Date2025-02-18

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