Company ยท US
Microgenics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2024. Name variants (Inc, Corp, punctuation) are merged.
128510(k) clearances (0 in 12 months)
15recalls (1 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DJG | Enzyme Immunoassay, Opiates | 13 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 13 |
| KXT | Enzyme Immunoassay, Digoxin | 9 |
| DKZ | Enzyme Immunoassay, Amphetamine | 8 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 7 |
| DLJ | Calibrators, Drug Specific | 7 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 7 |
| DKB | Calibrators, Drug Mixture | 6 |
| KLI | Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine | 6 |
| LAS | Drug Specific Control Materials | 5 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 5 |
| DIS | Enzyme Immunoassay, Barbiturate | 4 |
| CGN | Acid, Folic, Radioimmunoassay | 3 |
| DIF | Drug Mixture Control Materials | 3 |
| LAF | Gas Chromatography, Methamphetamine | 3 |
| LCM | Enzyme Immunoassay, Phencyclidine | 3 |
| MLM | Enzyme Immunoassay, Tracrolimus | 3 |
| OUF | Everolimus Immunoassay | 3 |
| CDD | Radioassay, Vitamin B12 | 2 |
| CGR | Radioimmunoassay, Cortisol | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 11, 2024 | K243498 | Alinity c Benzodiazepines Reagent Kit Microgenics Corporation | JXM |
| Oct 30, 2024 | K240670 | DRI Ecstasy Plus Assay Microgenics Corporation | DKZ |
| Nov 17, 2023 | K231020 | Alinity c Tricyclic Antidepressants Reagent Kit Microgenics Corporation | LFH |
| Sep 27, 2023 | K231007 | CEDIA Heroin Metabolite (6-AM) Assay Microgenics Corporation | DJG |
| Dec 21, 2022 | K213875 | DRI TM Tricyclics Serum Tox Assay Microgenics Corporation | LFH |
| Sep 24, 2021 | K211973 | DRI Cocaine Metabolite Assay Microgenics Corporation | DIO |
| Dec 16, 2019 | K192943 | CEDIA Heroin Metabolite (6-AM) assay Microgenics Corporation | DJG |
| Dec 9, 2019 | K190968 | CEDIA Benzodiazepine Assay Microgenics Corporation | JXM |
| Nov 19, 2018 | DEN180030 | QMS Plazomicin Immunoassay Microgenics Corporation | QDR |
| Jul 6, 2018 | K181499 | DRI Cocaine Metabolite Assay Microgenics Corporation | DIO |
| Feb 21, 2018 | K173963 | DRI Benzodiazepine Assay Microgenics Corporation | JXM |
| Feb 13, 2018 | K173195 | DRI Hydrocodone Assay Microgenics Corporation | DJG |
| Nov 22, 2017 | K173183 | CEDIA Heroin Metabolite (6-AM) Assay Microgenics Corporation | DJG |
| Apr 6, 2017 | K163101 | CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II C Microgenics Corporation | DJG |
| Oct 9, 2015 | K150502 | DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls Microgenics Corporation | DJG |
| Aug 20, 2013 | K122766 | THERMO SCIENTIFIC QMS EVEROLIMUS ASSAY Microgenics Corp. | OUF |
| Jul 11, 2013 | K123343 | THERMO SCIENTIFIC QMS TACROLIMUS ASSAY AND CALIBRATORS Microgenics Corp. | MLM |
| Jun 5, 2013 | K123518 | ABBOTT CARBAMAZEPINE ASSAY Microgenics Corporation | KLT |
| Apr 26, 2013 | K123271 | ABBOTT PHENOBARBITAL ASSAY Microgenics Corp. | DLZ |
| Dec 13, 2012 | K120936 | ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS Microgenics Corporation | DKB |
| Aug 31, 2012 | K122291 | THERMO SCIENTIFIC MAS OMNI-CARDIO Microgenics Corporation | JJY |
| Nov 3, 2011 | K110738 | THERMO SCIENTIFIC MAS OMNI-CORE Microgenics Corporation | JJY |
| Jun 29, 2011 | K110616 | THERMO SCIENTIFIC MAS OMNI-IMMUNE, MAS OMNI IMMUNE PRO Microgenics Corp. | JJY |
| Apr 8, 2011 | K101754 | THERMO SCIENTIFIC CEDIA OPIATE OFT ASSAY Microgenics Corp. | DJG |
| Apr 8, 2011 | K101753 | THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAY Microgenics Corp. | LAF |
| Apr 8, 2011 | K101752 | THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORS Microgenics Corp. | DKB |
| Apr 8, 2011 | K101746 | THERMO SCIENTIFIC CEDIA PHENCYCLIDINE (PCP) OFT ASSAY Microgenics Corp. | LCM |
| Apr 8, 2011 | K101745 | THERMO SCIENTIFIC CEDIA AMPHETAMINE OFT ASSAY Microgenics Corp. | DKZ |
| Apr 8, 2011 | K101744 | THERMO SCIENTIFIC CEDIA CANNABINOIDS OFT ASSAY Microgenics Corp. | LDJ |
| Apr 8, 2011 | K101742 | THERMO SCIENTIFIC CEDIA COCAINE OFT ASSAY Microgenics Corp. | DIO |
| Mar 24, 2011 | K103656 | THERMO SCIENTIFIC MAS R DOA TOTAL Microgenics Corporation | DIF |
| Feb 11, 2011 | K100144 | THERMO SCIENTIFIC QMS EVEROLIMUS REAGENTS, CALIBRATORS AND CONTROLS Microgenics Corp. | OUF |
| May 12, 2010 | K093114 | THERMO SCIENTIFIC DRI AMPHETAMINES ASSAY Microgenics Corp. | DKZ |
| Dec 3, 2009 | K092749 | MAS AND MINI-TROL PTH CONTROL Microgenics Corporation | JJX |
| Sep 21, 2009 | K092051 | THERMO SCIENTIFIC MAS CHEM TRAK & MONI TROL H LIQUID ASSAYED CHEMISTRY CONTROL, MODEL, CHA, CHU, M5155, M5158 Microgenics Corp. | JJY |
| Sep 18, 2009 | K090810 | THERMO SCIENTIFIC CYTO-CAL COUNT TUBES Microgenics Corp. | GKZ |
| May 30, 2006 | K061196 | CARDIOIMMUNE XL CARDIAC MARKER CONTROL Microgenics Corp. | JJY |
| Feb 3, 2006 | K053411 | DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS Microgenics Corp. | LCP |
| Jun 6, 2005 | K051074 | MAS IMMUNOSUPPRESSANT CONTROLS Microgenics Corp. | LAS |
| Mar 15, 2005 | K050206 | CEDIA TACROLIMUS ASSAY Microgenics Corp. | MLM |
| Jul 28, 2004 | DEN040008 | CEDIA SIROLIMUS ASSAY Microgenics Corp. | NRP |
| Jun 23, 2004 | K040316 | CEDIA BUPRENORPHINE ASSAY Microgenics Corp. | DJG |
| May 28, 2004 | K040758 | MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT Microgenics Corp. | DIF |
| May 27, 2004 | K040411 | DRI OXYCODONE ASSAY Microgenics Corp. | LAS |
| May 21, 2004 | K041073 | DOCUMENT SALICYLATE CAL VER Microgenics Corp. | JJY |
| Nov 24, 2003 | K032811 | CEDIA VANCOMYCIN ASSAY Microgenics Corp. | LEH |
| Oct 17, 2003 | K032842 | MICROGENICS CYCLOSPORINE CONTROL KIT Microgenics Corp. | LAS |
| Aug 27, 2003 | K023617 | DRI METHADONE METABOLITE ENZYME IMMUNOASSAY Microgenics Corp. | DJR |
| May 22, 2003 | K030649 | DRI COTININE EIA ASSAY Microgenics Corp. | MRS |
| Mar 31, 2003 | K030616 | CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 Microgenics Corp. | LAS |
Newest 50 of 128.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2026 | Microgenics Corporation MAS Omni IMMUNE PRO Liquid Assayed Integrated Immunoassay Control, Level 1, REF:
OPRO-101;
MAS Omni IMMUNETM PRO Liquid Assayed Integrated Immunoassay Control, Sample Pack, REF: OPRO-SP Open, Classified |
JJY | None listed |
| Oct 30, 2025 | Microgenics Corporation Thermo scientific MAS Omni CARDIO, Liquid Assayed Integrated Cardiac Control, Model/Catalog Number: OCRD-L, OCRD-101, OCRD-202, OCRD-303, OCRD-SP, OCRD-MP, OCRD-UL; Product Description: In Vitro Diagn Open, Classified |
JJY | None listed |
| Jan 20, 2022 | Microgenics Corporation QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET
QMS TACROLIMUS CAL A 10015566-3
QMS TACROLIMUS CAL B 10015567-3
QMS TACROLIMUS CAL C 10015568-3
QMS TACROLIMUS CAL D 10015569-3
QMS TACROLIMUS C Open, Classified |
MLM | K123343 |
| Oct 3, 2016 | Microgenics Corporation Thermo Scientific QMS Everolimus Assay;
Model number:
0380000 (US Distribution);
0373852 (Foreign Distribution)
Product Usage:
The QMS Everolimus Assay is intended for the quantitative determination Terminated |
OUF | K122766 |
| Sep 23, 2016 | Microgenics Corporation DRI Salicylate Serum Tox Assay, Catalog number 0977.
Toxicology:
The DRI Salicylate Serum Tox Assay is intended for the quantitative determination of salicylate in human serum or plasma. Terminated |
DKJ | K961131 |
| Dec 4, 2014 | Microgenics Corporation MAS CardioImmune XL Cardiac Marker Control;
Model: CAI-XL1;
intended for use in the clinical laboratory as an assayed control serum for monitoring assay conditions in specific cardiac marker determin Terminated |
JJY | K061196 |
| Jun 26, 2014 | Microgenics Corporation MAS Omni Immune PRO Controls Terminated |
JJY | K110616 |
| Jun 26, 2014 | Microgenics Corporation MAS Omni Immune Controls Terminated |
JJY | K110616 |
| Dec 16, 2013 | Microgenics Corp Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by
Microgenics Corporation, located at Fremont, CA., part of Therm Terminated |
LFW | K912143 |
| Sep 23, 2013 | Microgenics Corp DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories.
100 ml, IVD
Mfg by:
Microgenics Corporation,
46360 Fremont Blvd.
Fremont, CA 94538
The DRI Cocaine Metabolit Terminated |
DIO | K960187 |
| Jun 21, 2013 | Microgenics Corporation Thermo Scientific MAS Bilirubin for Siemens and Dimension Vista Systems, , Product is manufactured and distributed by Microgenics Corporation, Fremont, CA
MAS Bilirubin is intended for use as a cons Terminated |
JJX | K031890 |
| Nov 19, 2012 | Microgenics Corporation Thermo Scientific MAS Omni IMMUNE and Omni IMMUNE PRO;
Liquid Assayed Integrated Immunoassay Control.
Intended for use as an assayed control for monitoring assay conditions in many clinical laborator Terminated |
JJY | K110616 |
| Jan 17, 2012 | Microgenics Corp Tobramycin Calibrators, REF 7F93-01;
Microgenics Corporation, 46360 Fremont Blvd Fremont, CA 94538;
Distributed by Abbott Diagnostics, 100 Abbott Park Road, Abbott Park, Illinois 60064.
.Tobramyci Terminated |
DLJ | K872349 |
| Jan 11, 2012 | Microgenics Corporation ThermoFisher Scientific / Microgenics brand MAS CardioImmune XL, Liquid Assayed Cardiac Marker Control, in vitro diagnostic.
Catalog Numbers & Description:
CAI-XLL, Level L; CAI-XL1, Level 1; CAI-X Terminated |
JJY | K061196 |
| Nov 28, 2011 | Microgenics Corp Multigent Vancomycin Calibrators;
Manufactured by Microgenics Corp, Fremont, CA.
Distributed by: Abbott Diagnostics, Abbott Park, IL
Product Usage:
The Multigent Vancomycin calibrators are intended Terminated |
DLJ | K872644 |