Contract manufacturerMicrogenics Corporation (Fremont, CA)CaliforniaClinical toxicologyPathologyClinical chemistryHematologyClass IClass IIUnclassified
Microgenics Corporation
Contract manufacturer ยท Fremont, CA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010939897 (openFDA record; or search FDA's registration database)
- FEI number
- 3010939897
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer for export only; Manufacturer; Contract manufacturer
- Owner or operator
- Thermo Fisher Scientific (FDA owner/operator no. 2517925)
- Registered address
- 46500 Kato Road, Fremont, CA 94538
- Contract listings
- 65 device listings, 40 product codes, first listed Jul 3, 2003
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| DIF | Drug Mixture Control Materials | Class I | Clinical toxicology | Contract manufacturing | Jan 13, 2006 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | Class II | Clinical toxicology | Contract manufacturing | Jan 13, 2006 |
| DIP | Enzyme Immunoassay, Diphenylhydantoin | Class II | Clinical toxicology | Contract manufacturing | Mar 21, 2014 |
| DIS | Enzyme Immunoassay, Barbiturate | Class II | Clinical toxicology | Contract manufacturing | Jan 13, 2006 |
| DJG | Enzyme Immunoassay, Opiates | Class II | Clinical toxicology | Contract manufacturing | Jan 13, 2006 |
| DJR | Enzyme Immunoassay, Methadone | Class II | Clinical toxicology | Contract manufacturing | Feb 27, 2008 |
| DKB | Calibrators, Drug Mixture | Class II | Clinical toxicology | Contract manufacturing | Jan 13, 2006 |
| DKC | Alcohol Control Materials | Class I | Clinical toxicology | Contract manufacturing | Jan 13, 2006 |
| DKZ | Enzyme Immunoassay, Amphetamine | Class II | Clinical toxicology | Contract manufacturing | Feb 27, 2008 |
| DLJ | Calibrators, Drug Specific | Class II | Clinical toxicology | Contract manufacturing | Aug 6, 2008 |
| DLZ | Enzyme Immunoassay, Phenobarbital | Class II | Clinical toxicology | Contract manufacturing | Nov 13, 2013 |
| DMT | Enzymatic Method, Alcohol Dehydrogenase, Ultraviolet | Class II | Clinical toxicology | Contract manufacturing | Jan 13, 2006 |
| DNN | Calibrators, Ethyl Alcohol | Class II | Clinical toxicology | Contract manufacturing | Jan 13, 2006 |
| IBG | Trypsin | Class I | Pathology | Contract manufacturing | Dec 11, 2014 |
| IGC | Formalin-Saline | Class I | Pathology | Contract manufacturing | Dec 11, 2014 |
| IGD | Solution, Formol Calcium | Class I | Pathology | Contract manufacturing | Dec 11, 2014 |
| JGJ | Photometric Method, Magnesium | Class I | Clinical chemistry | Contract manufacturing | Nov 1, 2017 |
| JIT | Calibrator, Secondary | Class II | Clinical chemistry | Contract manufacturing | Sep 4, 2013 |
| JIX | Calibrator, Multi-Analyte Mixture | Class II | Clinical chemistry | Contract manufacturing | Feb 11, 2013 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | Class I | Clinical chemistry | Contract manufacturing | Feb 27, 2008 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | Class I | Clinical chemistry | Contract manufacturing | Nov 24, 2009 |
| JMO | Ferrozine (Colorimetric) Iron Binding Capacity | Class I | Clinical chemistry | Contract manufacturing | Sep 4, 2013 |
| JXM | Enzyme Immunoassay, Benzodiazepine | Class II | Clinical toxicology | Contract manufacturing | Jan 13, 2006 |
| JXN | Enzyme Immunoassay, Propoxyphene | Class II | Clinical toxicology | Contract manufacturing | Aug 6, 2008 |
| KLQ | Radioimmunoassay, Amikacin | Class II | Clinical toxicology | Contract manufacturing | Nov 28, 2007 |
| KLS | Enzyme Immunoassay, Theophylline | Class II | Clinical toxicology | Contract manufacturing | Mar 21, 2014 |
| KLT | Enzyme Immunoassay, Carbamazepine | Class II | Clinical toxicology | Contract manufacturing | Nov 13, 2013 |
| KXT | Enzyme Immunoassay, Digoxin | Class II | Clinical toxicology | Contract manufacturing | Nov 28, 2007 |
| LAF | Gas Chromatography, Methamphetamine | Class II | Clinical toxicology | Contract manufacturing | Nov 5, 2014 |
| LAS | Drug Specific Control Materials | Class I | Clinical toxicology | Contract manufacturing | Jun 1, 2017 |
| LBZ | Enzyme Immunoassay, Quinidine | Class II | Clinical toxicology | Contract manufacturing | Aug 7, 2008 |
| LCD | Enzyme Immunoassay, Gentamicin | Class II | Clinical toxicology | Contract manufacturing | Aug 7, 2008 |
| LCM | Enzyme Immunoassay, Phencyclidine | Unclassified | Clinical toxicology | Contract manufacturing | Feb 27, 2008 |
| LCR | Fluorescent Immunoassay, Tobramycin | Class II | Clinical toxicology | Contract manufacturing | Nov 28, 2007 |
| LDJ | Enzyme Immunoassay, Cannabinoids | Class II | Clinical toxicology | Contract manufacturing | Jan 13, 2006 |
| LEG | Enzyme Immunoassay, Valproic Acid | Class II | Clinical toxicology | Contract manufacturing | Nov 28, 2007 |
| LEH | Radioimmunoassay, Vancomycin | Class II | Clinical toxicology | Contract manufacturing | Aug 7, 2008 |
| MXZ | Immunohistochemistry Assay, Antibody, Progesterone Receptor | Class II | Hematology | Contract manufacturing | Nov 12, 2007 |
| MYA | Immunohistochemistry Antibody Assay, Estrogen Receptor | Class II | Hematology | Contract manufacturing | Nov 12, 2007 |
| NJT | Immunohistochemistry Reagents And Kits | Class I | Hematology | Contract manufacturing | Jul 3, 2003 |