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Sign in to claim this brandMicrogenics Corporation
United States·US-MF-000030375
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 46500 , Kato Road, Fremont, United States
- Website
- www.thermofisher.com/diagnostics
This website did not respond in time when we last checked. Last checked 2026-09-18.
- —
- —
- [email protected]
- Phone
- 001-510-979-5000
- PRRC Contact
- Mark Brandes
- EUDAMED SRN
- US-MF-000030375
- FDA FEI Number
- 3010939897
- DUNS Number
- —
Catalogue (706)
Page 5 of 15| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| QMS Zonisamide Assay | 10017230 | EUDAMEDFDA UDI | IVD General | Active |
| DRI Ethyl Glucuronide 375 ng/mL Control | 10012135 | EUDAMED | IVD General | Active |
| MAS Immunology Liquid Assayed Immunology Control | IC-303 | EUDAMEDFDA UDI | IVD General | Active |
| Cedia Digoxin Plus Assay | K941255 | FDA 510(k) | Class II | Active |
| Dridau Opiate Assay | K011150 | FDA 510(k) | Class II | Active |
| Cedia Digoxin Cr Assay | K872583 | FDA 510(k) | Class II | Active |
| Cedia Total T4 Assay | K852164 | FDA 510(k) | Class II | Active |
| Cedia(r) Dau Opiate Assay | K935346 | FDA 510(k) | Class II | Active |
| Thermo Scientific Cedia Multi-Drug Oft Calibrators | K101752 | FDA 510(k) | Class II | Active |
| Microgenics Cyclosporine Control Kit | K032842 | FDA 510(k) | Class I | Active |
| Cedia(r) Dau Pcp Assay | K935650 | FDA 510(k) | U | Active |
| Dri Methadone Metabolite Enzyme Immunoassay | K023617 | FDA 510(k) | Class II | Active |
| Thermo Scientific Cedia Opiate Oft Assay | K101754 | FDA 510(k) | Class II | Active |
| Cedia Dau Benzodiazepine Assay | K940159 | FDA 510(k) | Class II | Active |
| Cedia Dau Thc Calibrators | K935795 | FDA 510(k) | Class II | Active |
| Thermo Scientific Cedia Cannabinoids Oft Assay | K101744 | FDA 510(k) | Class II | Active |
| Mas And Mini-Trol Pth Control | K092749 | FDA 510(k) | Class I | Active |
| Cedia Tacrolimus Assay | K050206 | FDA 510(k) | Class II | Active |
| Cedia Dau Multi-Level Thc Assay | K942337 | FDA 510(k) | Class II | Active |
| Cedia(r) Gentamicin Assay | K913470 | FDA 510(k) | Class II | Active |
| Cedia Digoxin Assay (modification) | K920214 | FDA 510(k) | Class II | Active |
| Dri Primidone Calibrators | K023780 | FDA 510(k) | Class II | Active |
| Cedia(r) Digoxin R' Assay | K911941 | FDA 510(k) | Class II | Active |
| Cedia Dau Opiate Assay | K941195 | FDA 510(k) | Class II | Active |
| Multi Level Thc Assay, Synchron Cx Reagent Application | K944562 | FDA 510(k) | Class II | Active |
| Cedia(r) Dau Pcp Assay | K946059 | FDA 510(k) | U | Active |
| DRI TM Tricyclics Serum Tox Assay | K213875 | FDA 510(k) | Class II | Active |
| Abbott Phenobarbital Assay | K123271 | FDA 510(k) | Class II | Active |
| Mas Immunosuppressant Controls | K051074 | FDA 510(k) | Class I | Active |
| Dri Cotinine Eia Assay | K030649 | FDA 510(k) | Class I | Active |
| Thermo Scientific Mas Omni-Core | K110738 | FDA 510(k) | Class I | Active |
| Thermo Scientific Mas Omni-Cardio | K122291 | FDA 510(k) | Class I | Active |
| Cedia(r) Digoxin Sc Assay | K910642 | FDA 510(k) | Class II | Active |
| Mgc Dau Control Sets: Primary, Clinical And Select | K040758 | FDA 510(k) | Class I | Active |
| Cedia Dau Barbiturate Assay | K945344 | FDA 510(k) | Class II | Active |
| Cedia(r) Theophylline Assay/Modification | K905521 | FDA 510(k) | Class II | Active |
| Cedia Ferritin Assay | K920318 | FDA 510(k) | Class II | Active |
| Cedia T4 Mab Assay Modification | K935880 | FDA 510(k) | Class II | Active |
| Cedia Dau Propoxyphene Assay | K951133 | FDA 510(k) | Class II | Active |
| Cedia Cortisol Assay | K893954 | FDA 510(k) | Class II | Active |
| Cedia Dau 6-Acetylmorphine Assay | K001178 | FDA 510(k) | Class II | Active |
| Abbott Tdm Multiconstituent Calibrator, Thermo Scientific Qms Multi-Constituent Calibrators | K120936 | FDA 510(k) | Class II | Active |
| Cedia(r) Tobramycin Assay | K912143 | FDA 510(k) | Class II | Active |
| Cedia Digoxin Plus Assay | K934168 | FDA 510(k) | Class II | Active |
| Cedia Dau Amphetamines Assay | K951154 | FDA 510(k) | Class II | Active |
| Cedia Dau Ppx/Meth Calibrator | K951153 | FDA 510(k) | Class II | Active |
| Cedia Dau Lsd Assay | K955814 | FDA 510(k) | Class II | Active |
| Cedia Cyclosporine Plus High Range Controls 4 And 5 | K030616 | FDA 510(k) | Class I | Active |
| Cedia Dau Lsd Calbirators | K955813 | FDA 510(k) | Class II | Active |
| Cedia Cyclosporine Plus Assay | K023208 | FDA 510(k) | Class II | Active |
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FDA Recalls (14)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 1, 2025 | Z-0415-2026 | — | open, classified | The firm received complaints from customers reporting vial-to-vial variability when using the control with high sensitivity Troponin I assays. This defect may lead to as delay in patient results for hs Troponin I assays. |
| Jan 20, 2022 | Z-1284-2022 | — | open, classified | Due to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result values when used with the QMS Tacrolimus Immunoassay. |
| Aug 15, 2016 | Z-0008-2017 | — | terminated | A reagent stability issue (still under investigation) causes less separation in the calibration curve, which affects results across the entire range. For controls, maximum bias of +/- 35% for low levels, +/- 33% for mid-range levels, and +/- 47% for high levels is observed. Bias in patient samples ranges from -15.7% to +5.2% with an average bias of -5.6% when comparing the QMS everolimus assay to an everolimus LC-MS reference method. Patient samples across the measuring range sub-therapeutic, therapeutic, and supra-therapeutic could be affected. |
| Jul 25, 2016 | Z-2884-2016 | — | terminated | Some lots of DRI Salicylate Serum Tox Assay negative patient samples are recovering higher than the product sensitivity claim of 4.4 mg/dL. |
| Oct 20, 2014 | Z-0501-2015 | — | terminated | MAS CardioImmune XL, level 1 (lot CXL16011), is showing vial-to-vial variation for the analytes Creatine Kinase-MB (CK-MB) and B-Type Natriuretic Peptide-32 (BNP-32). |
| Dec 2, 2013 | Z-1930-2014 | — | terminated | The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change. |
| Dec 2, 2013 | Z-1929-2014 | — | terminated | The constituent, Inhibin A, was removed from MAS Omni IMMUNE and MAS Omni IMMUNE PRO controls; however the package insert was not updated to reflect the change. |
| Oct 16, 2013 | Z-0513-2014 | — | terminated | Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due to calibration stability problem relating to two complaints received. |
| Jul 23, 2013 | Z-2267-2013 | — | terminated | Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing change in the reaction rate, indicating a faster than expected reagent degradation. |
| May 13, 2013 | Z-1563-2013 | — | terminated | It has been confirmed from in-house testing that Direct Bilirubin (DBIL), and Total Bilirubin (TBIL) claimed in Thermo Scientific MAS Bilirubin Systems are displaying reduced stability. |
| Aug 20, 2012 | Z-0379-2013 | — | terminated | In house testing confirmed that CK-MS and Insulin claimed in both Omni IMMUNE and Omni IMMUNE PRO products are displaying reduced stability. |
| Dec 14, 2011 | Z-0637-2012 | — | terminated | Low measurements of Troponin I in the MAS CardioImmune XL Control which were outside the published control ranges. |
| Nov 11, 2011 | Z-0773-2012 | — | terminated | Reports that third party control material for 4 lots of Tobramycin Calibrators that are recovering low and outside of the published range. |
| Jun 8, 2011 | Z-0297-2012 | — | terminated | Complaint from the sole distributor that the third party control material is recovering high, and outside the published range. |