PreciControl Anti-CMV 04784600162

GUDID 07613336183151

Roche Diagnostics GmbH

Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, control
Primary Device ID07613336183151
NIH Device Record Keyb44e6a08-26e4-403e-860a-c04c6756ef03
Commercial Distribution StatusIn Commercial Distribution
Brand NamePreciControl Anti-CMV
Version Model Number04784600162
Catalog Number04784600162
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
GS107613336183151 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MZETest, donor, CMV

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-12-13
Device Publish Date2023-12-05

Devices Manufactured by Roche Diagnostics GmbH

07613336227763 - Sodium electrode2025-03-13
07613336227770 - Potassium electrode2025-03-13
07613336227787 - Chloride electrode2025-03-13
07613336227794 - Reference electrode2025-03-13
07613336183045 - PreciControl Release HIV Gen II2025-02-27
07613336228487 - Elecsys Anti-HBc II2025-02-27
07613336228500 - Elecsys HIV Duo2025-02-27
07613336183212 - PreciControl HIV Gen II2025-02-27

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