Separator, Automated, Blood Cell, Diagnostic (GKT) contract manufacturers
16 US facilities list FDA product code GKT as a contract manufacturer (3) or contract sterilizer (13).
FDA-registered (openFDA, export of Oct 21, 2026)
- FDA device name
- Separator, Automated, Blood Cell, Diagnostic
- Product code
- GKT (FDA product classification database)
- Device class
- Class II
- Regulation
- 21 CFR 864.9245
- Classification panel
- Hematology
Where they are
California 6 · Ohio 3 · Colorado 2 · New Jersey 2 · Illinois 1 · Pennsylvania 1 · Texas 1
All 16 facilities
| Company | FDA registration | Establishment type | Device categories | City and state | Certification | Updated |
|---|---|---|---|---|---|---|
| BGS US LLC | 3032902763 | Contract sterilizer | Hematology; Cardiovascular | Imperial, PA | Not verified | Oct 21, 2026 |
| Comar | 3004601221 | Contract manufacturer | Hematology | Rancho Cucamonga, CA | Not verified | Oct 21, 2026 |
| COMAR, LLC | 2220100 | Contract manufacturer | Hematology; General hospital | Buena, NJ | Not verified | Oct 21, 2026 |
| E-BEAM SERVICES, INC. | 1531062 | Contract sterilizer | General and plastic surgery; Clinical chemistry; Cardiovascular +9 more | Lebanon, OH | Not verified | Oct 21, 2026 |
| E-BEAM SERVICES, INC. | 2245437 | Contract sterilizer | Clinical chemistry; Hematology; General hospital +3 more | Cranbury, NJ | Not verified | Oct 21, 2026 |
| ISOMEDIX OPERATIONS INC | 1526711 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +10 more | Groveport, OH | 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 |
| Isomedix Operations, Inc | 2032098 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +12 more | Ontario, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029015 | Contract sterilizer | General and plastic surgery; Gastroenterology and urology; General hospital +13 more | Ontario, CA | Not verified | Oct 21, 2026 |
| Sterigenics U.S., LLC | 2029275 | Contract sterilizer | General and plastic surgery; Orthopedic; Cardiovascular +16 more | Corona, CA | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1423662 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Gurnee, IL | Not verified | Oct 21, 2026 |
| Sterigenics US LLC | 1649518 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +13 more | Fort Worth, TX | Not verified | Oct 21, 2026 |
| Sterigenics US, LLC | 1526534 | Contract sterilizer | Orthopedic; General and plastic surgery; General hospital +14 more | Lewis Center, OH | Not verified | Oct 21, 2026 |
| Synergy Health AST, LLC | 3012102437 | Contract sterilizer | Cardiovascular; General and plastic surgery; Orthopedic +6 more | Petaluma, CA | Not verified | Oct 21, 2026 |
| Terumo BCT STERILIZATION SERVICES, Inc. | 1724474 | Contract sterilizer | Cardiovascular; General and plastic surgery; Gastroenterology and urology +6 more | Lakewood, CO | Not verified | Oct 21, 2026 |
| TERUMO BCT, INC.- Littleton | 3017581284 | Contract manufacturer | Hematology | Highlands Ranch, CO | Not verified | Oct 21, 2026 |
Related hematology product codes
- ORG Platelet And Plasma Separator For Bone Graft Handling (33)
- KIZ Dish, Tissue Culture (14)
- KJF System, Suspension, Cell Culture (14)
- KSR Container, Empty, For Collection & Processing Of Blood & Blood Components (13)
- KJA Flask, Tissue Culture (10)
- GKZ Counter, Differential Cell (8)
- GGK Products, Red-Cell Lysing Products (7)
- KHE Reagent, Occult Blood (7)