MAS anti-HBs Positive Control

GUDID 00884883007529

Microgenics Corporation

Hepatitis B virus antigen/antibody marker IVD, control
Primary Device ID00884883007529
NIH Device Record Key46a8362a-1913-432f-aeb8-973688abbcb3
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS anti-HBs Positive Control
Version Model Number10027482
Company DUNS122153799
Company NameMicrogenics Corporation
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
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
GS100884883007529 [Primary]

FDA Product Code

OHQMulti-Analyte Controls Unassayed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-08
Device Publish Date2020-06-30

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