CEDIA Antibiotic TDM Multi-Cal

GUDID 00884883007116

Microgenics Corporation

Multiple-therapy therapeutic drug monitoring IVD, calibrator
Primary Device ID00884883007116
NIH Device Record Key8cc81234-2767-4a85-ba02-d15395845a72
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Antibiotic TDM Multi-Cal
Version Model Number08777934 190
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100884883007116 [Primary]

FDA Product Code

DKBCalibrators, Drug Mixture

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-11-28
Device Publish Date2019-11-20

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