Microgenics Corporation

FDA Filings

This page includes the latest FDA filings for Microgenics Corporation. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Microgenics Corporation
DRI Cocaine Metabolite Assay2018-07-06
Microgenics Corporation
DRI Benzodiazepine Assay2018-02-21
Microgenics Corporation
DRI Hydrocodone Assay2018-02-13
Microgenics Corporation
CEDIA Heroin Metabolite (6-AM) Assay2017-11-22
MICROGENICS CORPORATION
CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set2017-04-06
Microgenics Corporation
DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls2015-10-09
MICROGENICS CORP.
THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY2013-08-20
MICROGENICS CORP.
THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS2013-07-11
Microgenics Corporation
ABBOTT CARBAMAZEPINE ASSAY2013-06-05
MICROGENICS CORP.
ABBOTT PHENOBARBITAL ASSAY2013-04-26
Microgenics Corporation
THERMO SCIENTIFIC MAS OMNI-CARDIO2012-08-31
Microgenics Corporation
THERMO SCIENTIFIC MAS OMNI-CORE2011-11-03
MICROGENICS CORP.
THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO2011-06-29
MICROGENICS CORP.
THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY2011-04-08
MICROGENICS CORP.
THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY2011-04-08
MICROGENICS CORP.
THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS2011-04-08
Microgenics Corporation
THERMO SCIENTIFIC MAS R DOA TOTAL2011-03-24
MICROGENICS CORP.
THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY2010-05-12
Microgenics Corporation
MAS AND MINI-TROL PTH CONTROL2009-12-03
MICROGENICS CORP.
THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M51582009-09-21
MICROGENICS CORP.
CARDIOIMMUNE XL CARDIAC MARKER CONTROL2006-05-30
MICROGENICS CORP.
CEDIA BUPRENORPHINE ASSAY2004-06-23
MICROGENICS CORP.
MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT2004-05-28
MICROGENICS CORP.
DRI OXYCODONE ASSAY2004-05-27
MICROGENICS CORP.
DRI METHADONE METABOLITE ENZYME IMMUNOASSAY2003-08-27
MICROGENICS CORP.
DRI COTININE EIA ASSAY2003-05-22
MICROGENICS CORP.
CEDIA CYCLOSPORINE PLUS ASSAY2002-10-24
MICROGENICS CORP.
DRI ECSTASY URINE CALIBRATORS2001-08-27
MICROGENICS CORP.
DRIDAU OPIATE ASSAY2001-06-20
MICROGENICS CORP.
CEDIA DAU 6-ACETYLMORPHINE ASSAY2000-06-09

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Microgenics Corporation
QMS Plazomicin Immunoassay2018-11-19

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
QMS Quinidine Immunoassay Calibrator Set
Microgenics Corporation2019-11-21
AcroMetrix Oncology Hotspot Control
Microgenics Corporation2019-10-23
DRI pH-Detect 10.0 Control Kit
Microgenics Corporation2019-07-10
DRI pH-Detect pH 7.0 Control Kit
Microgenics Corporation2019-07-10
DRI pH-Detect pH 3.0 and 11.0 Calibrator Kit
Microgenics Corporation2019-07-10
DRI pH-Detect pH 3.6 Control Kit
Microgenics Corporation2019-07-10
DRI pH-Detect pH 11.5 Control Kit
Microgenics Corporation2019-07-10
CEDIA MultiDrug Optional Controls
Microgenics Corporation2019-07-10
MAS Cardioimmune Ultra Low
Microgenics Corporation2019-07-10
DRI pH-Detect Test
Microgenics Corporation2019-07-10
DRI pH Detect
Microgenics Corporation2019-07-10
CEDIA Negative Calibrator
Microgenics Corporation2019-07-09
CEDIA Buprenorphine II 20ng/mL Calibrator
Microgenics Corporation2019-07-09
CEDIA Buprenorphine II 50ng/mL Calibrator
Microgenics Corporation2019-07-09
CEDIA Buprenorphine II 100ng/mL Calibrator
Microgenics Corporation2019-07-09
CEDIA T Uptake
Microgenics Corporation2019-07-09
DRI T-Uptake Calibrator Kit
Microgenics Corporation2019-07-09
DRI Thyroxine (T4) Calibrator Kit
Microgenics Corporation2019-07-09
DRI Cotinine High Control
Microgenics Corporation2019-07-09
DRI Cotinine Low Control
Microgenics Corporation2019-07-09
DRI Cotinine Calibrator Kit
Microgenics Corporation2019-07-09
DRI Cotinine Assay
Microgenics Corporation2019-07-09
DRI Methadone Metabolite 2000 ng/mL Calibrator
Microgenics Corporation2019-07-09
DRI Methadone Metabolite 1000 ng/mL Calibrator
Microgenics Corporation2019-07-09
DRI Methadone Metabolite 300 ng/mL Calibrator
Microgenics Corporation2019-07-09
DRI Methadone Metabolite 150 ng/mL Calibrator
Microgenics Corporation2019-07-09
CEDIA Buprenorphine II Controls
Microgenics Corporation2019-07-09
QMS Everolimus Immunoassay Control Set
Microgenics Corporation2019-07-09
MAS Alcohol/Ammonia
Microgenics Corporation2019-07-09
DRI Methadone Metabolite Assay
Microgenics Corporation2019-07-09
DRI Cotinine Assay
Microgenics Corporation2019-07-09
MAS Alcohol/Ammonia
Microgenics Corporation2019-07-09
CEDIA Buprenorphine II 10ng/mL Calibrator
Microgenics Corporation2019-07-09
DRI T-Uptake
Microgenics Corporation2019-07-09
DRI Methadone Metabolite Assay
Microgenics Corporation2019-07-09

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