Werfen
Diagnostics makerAI. FDA files no records under this name; these are its 10 companies' records, each linked to the record.
- Records across the group: 719, 11 entitiesAI
- 510(k) clearances: 625
- Device recalls: 94
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date, Werfen and its 10 subsidiaries
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Mar 20, 2026 | HemosIL Factor V Leiden (APC Resistance V)K260551 · GGW | 510(k) clearances |
| Feb 6, 2026 | Aptiva APS IgA ReagentK243979 · MSV | 510(k) clearances |
| Jan 9, 2026 | HemosIL Silica Clotting TimeK253957 · GFO | 510(k) clearances |
| Jul 24, 2025 | HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLK251968 · KQJ | 510(k) clearances |
| Feb 12, 2025 | ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG ControlsK243575 · MYF | 510(k) clearances |
| Jan 28, 2025 | HemosIL CL HIT-IgG(PF4-H)K243374 · LCO | 510(k) clearances |
| Dec 17, 2024 | Aptiva APS IgG Reagent; Aptiva APS IgM ReagentK223093 · MID | 510(k) clearances |
| Aug 16, 2024 | ACL TOP Family 50 Series (ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS; ACL TOP 550 CTS; ACL TOP 350 CTS)K242127 · GKP | 510(k) clearances |
Subsidiaries and Divisions
10 firms in the Werfen group, most records first- Instrumentation Laboratory410 records
- Inova Diagnostics138 records
- Immco Diagnostics55 records
- International Technidyne Corp.49 records
- Biokit24 records
- Biokit USA16 records
- Accumetrics11 records
- Accriva Diagnostics, Inc.10 records
- Chromogenix4 records
- Immucor GTI Diagnostics, Inc.2 records
Canada and Imports
Across the Werfen group, matched by company name- Active Health Canada device licences
- 318, as of Nov 10, 2026
Names and Identifiers
- Appears as
- Website
- werfen.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