DRI Methadone Metabolite 300 ng/mL Calibrator

GUDID 00884883005099

Microgenics Corporation

Multiple drugs of abuse IVD, calibrator
Primary Device ID00884883005099
NIH Device Record Key78db55d1-cbfd-48f6-ae61-41822f709a98
Commercial Distribution StatusIn Commercial Distribution
Brand NameDRI Methadone Metabolite 300 ng/mL Calibrator
Version Model Number100118
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
GS100884883005099 [Primary]

FDA Product Code

DJREnzyme Immunoassay, Methadone
DLJCalibrators, Drug Specific

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2019-07-09
Device Publish Date2016-09-12

Devices Manufactured by Microgenics Corporation

00884883006027 - Acrometrix BB NAT HBV Positive Control2022-10-17
00884883007376 - MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays2021-11-11
07613336190791 - OXY DRI Oxycodone2021-11-03
00884883007383 - MAS anti-HBs Positive Control – For use with Siemens Assays 2021-05-13
00884883007765 - MAS SARS-CoV-2 IgG Positive Control2021-03-15
00884883007772 - MAS SARS-CoV-2 Negative Control2021-03-15
07613336154045 - OXY Oxycodone2020-09-17
00884883007505 - MAS Omni Infectious BSI Positive Control Panel2020-07-08

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.