CEDIA Buprenorphine II 10ng/mL Calibrator

GUDID 00884883003491

Microgenics Corporation

Buprenorphine IVD, calibrator
Primary Device ID00884883003491
NIH Device Record Key14cb6731-4054-48ae-b496-dda54b137836
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Buprenorphine II 10ng/mL Calibrator
Version Model Number10020799
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
GS100884883003491 [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

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