CEDIA Gentamicin II (GENTC)

GUDID 07613336190807

Microgenics Corporation

Gentamicin therapeutic drug monitoring IVD, kit, enzyme immunoassay (EIA)
Primary Device ID07613336190807
NIH Device Record Keyf216b32e-ad0e-44aa-bb86-6d6e9b2378ba
Commercial Distribution StatusIn Commercial Distribution
Brand NameCEDIA Gentamicin II (GENTC)
Version Model Number09026924 190
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 Numbertrue
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107613336190807 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCDEnzyme Immunoassay, Gentamicin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-01
Device Publish Date2020-06-23

Devices Manufactured by Microgenics Corporation

00884883008830 - MAS Diabetes Max-SP (Sample-Pack)2024-05-29
00884883008823 - MAS Diabetes Max, Multi-pack2024-05-28
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

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