CEDIA Heroin Metabolite (6-AM) Assay

GUDID 00884883004306

Microgenics Corporation

6-Acetyl morphine IVD, reagent
Primary Device ID00884883004306
NIH Device Record Keyfd980b4a-e4df-47cb-9658-f945585d0868
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Heroin Metabolite (6-AM) Assay
Version Model Number100186
Company DUNS122153799
Company NameMicrogenics Corporation
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 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
GS100884883004306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates
JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2019-04-30
Device Publish Date2016-09-21

On-Brand Devices [CEDIA Heroin Metabolite (6-AM) Assay]

0088488301136610015213
00884883004306100186
00884883004245100108
00884883001558100107

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