MAS Urinalysis Liquid Urinalysis Control 3

GUDID 00884883004153

Microgenics Corporation

Multiple urine analyte IVD, control
Primary Device ID00884883004153
NIH Device Record Keyae808354-0bdd-41da-9208-e42572f19ffb
Commercial Distribution StatusIn Commercial Distribution
Brand NameMAS Urinalysis Liquid Urinalysis Control 3
Version Model Number024224
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883004153 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JJWUrinalysis Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-04-29
Device Publish Date2018-02-12

On-Brand Devices [MAS Urinalysis Liquid Urinalysis Control 3]

00884883004160024227
00884883004153024224

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