CEDIA Negative Calibrator

GUDID 00884883006065

Microgenics Corporation

Buprenorphine IVD, calibrator
Primary Device ID00884883006065
NIH Device Record Keye2a98d06-302e-48cf-86b2-fa0bfc8136a0
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Negative Calibrator
Version Model Number10021390
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
GS100884883006065 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DLJCalibrators, Drug Specific

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-07-09
Device Publish Date2017-05-12

On-Brand Devices [CEDIA Negative Calibrator]

008848830114891557416
0088488300606510021390
008848830019611661388

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