Microgenics
Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Thermo Fisher ScientificLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 4 spellings of its name, each linked to the record.
- 510(k) clearances: 126
- Device recalls: 12
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Dec 11, 2024 | Alinity c Benzodiazepines Reagent KitK243498 · JXM | 510(k) clearances |
| Oct 30, 2024 | DRI Ecstasy Plus AssayK240670 · DKZ | 510(k) clearances |
| Nov 17, 2023 | Alinity c Tricyclic Antidepressants Reagent KitK231020 · LFH | 510(k) clearances |
| Sep 27, 2023 | CEDIA Heroin Metabolite (6-AM) AssayK231007 · DJG | 510(k) clearances |
| Dec 21, 2022 | DRI TM Tricyclics Serum Tox AssayK213875 · LFH | 510(k) clearances |
| Sep 24, 2021 | DRI Cocaine Metabolite AssayK211973 · DIO | 510(k) clearances |
| Dec 16, 2019 | CEDIA Heroin Metabolite (6-AM) assayK192943 · DJG | 510(k) clearances |
| Dec 9, 2019 | CEDIA Benzodiazepine AssayK190968 · JXM | 510(k) clearances |
| Oct 16, 2013 | Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by MiClass II · Microgenics Corp., part of Thermo Fisher Scientific, is recalling CEDIA Tobramycin II Assay (Lot Number: 60169764) due t | Device recalls |
| Jul 23, 2013 | DRI Cocaine Metabolite Assay, labeled as Multigent Cocaine Assay for Abbott Laboratories. 100 ml, IVD Mfg by: Microgenics Corporation, Class II · Surveillance of reagent stability for specific lots of DRI Cocaine Metabolite Reagent show an unexpected decreasing cha | Device recalls |
Canada and Imports
Matched by company name- Active Health Canada device licences
- 173, as of Nov 10, 2026
Names and Identifiers
- Appears as
- Website
- thermofisher.com
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built