Counter, Differential Cell (GKZ) contract manufacturers
8 US facilities list FDA product code GKZ as a contract manufacturer (7) or contract sterilizer (1).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Counter, Differential Cell
- Product code
- GKZ (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 864.5220
- Classification panel
- Hematology
Where they are
California 2 · Illinois 2 · Florida 1 · Nebraska 1 · Puerto Rico 1 · Virginia 1
All 8 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. | 1017835 | Contract manufacturer | Hematology; Pathology | Hialeah, FL | 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 |
| Isomedix Operations Inc. | 2032112 | Contract sterilizer | Cardiovascular; General hospital; Gastroenterology and urology +13 more | San Diego, CA | Not verified | Oct 21, 2026 |
| STRECK LLC | 1950302 | Contract manufacturer | Hematology | La Vista, NE | Not verified | Oct 21, 2026 |
| Sysmex America, Inc. | 3009495621 | Contract manufacturer | Clinical chemistry; Hematology | Buffalo Grove, IL | Not verified | Oct 21, 2026 |
| Sysmex America, Inc. - Vernon Hills | 3020704087 | Contract manufacturer | Clinical chemistry; Hematology | Vernon Hills, IL | Not verified | Oct 21, 2026 |
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