Counter, Cell, Automated (Particle Counter) (GKL) contract manufacturers
5 US facilities list FDA product code GKL as a contract manufacturer (5) or contract sterilizer (0).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Counter, Cell, Automated (Particle Counter)
- Product code
- GKL (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 864.5200
- Classification panel
- Hematology
Where they are
California 1 · Minnesota 1 · Nebraska 1 · Puerto Rico 1 · Virginia 1
All 5 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| ANTIBODIES INCORPORATED | 2914537 | Contract manufacturer | Hematology; Pathology | Davis, CA | Not verified | Oct 21, 2026 |
| BECKMAN COULTER, INC. | 2122870 | Contract manufacturer | Clinical chemistry; Hematology; Immunology | Chaska, MN | Not verified | Oct 21, 2026 |
| Becton Dickinson Caribe, LTD | 3008352382 | Contract manufacturer | Hematology; Pathology; Immunology | Cayey, PR | Not verified | Oct 21, 2026 |
| Fisher Diagnostics | 1181121 | Contract manufacturer | Clinical chemistry; Immunology; Hematology +4 more | Middletown, VA | Not verified | Oct 21, 2026 |
| STRECK LLC | 1950302 | Contract manufacturer | Hematology | La Vista, NE | Not verified | Oct 21, 2026 |
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