Is this your brand? Sign in to claim ownership.
Sign in to claim this brandImmucor GTI Diagnostics, Inc.
United States·US-MF-000020921
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 20925, Crossroads Circle, Waukesha, United States
- Website
- immucor.com
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Amy Cochran
- EUDAMED SRN
- US-MF-000020921
- FDA FEI Number
- 2183608
- DUNS Number
- —
Catalogue (95)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Negative Serum Control | 404572 | FDA UDI | Class II | Unknown |
| Positive Serum Control | 404600 | FDA UDI | Class II | Unknown |
| ThromboType®1 | THROMBOTYPE1 | FDA UDI | Class II | Active |
| LIFECODES Wash Buffer | 628221 | FDA UDI | U | Unknown |
| PF4 Enhanced® | X-HAT45 | FDA UDI | Class II | Active |
| 3 x 4% E-Gel 48 Gels | EGEL48 | FDA UDI | Class II | Active |
| Positive Serum Control | 404601 | FDA UDI | Class II | Unknown |
| LIFECODES MATCH IT!™ DNA Software v1.2 | 888623 | FDA UDI | U | Unknown |
| PakPlus® | PAKPLUS100 | FDA UDI | Class II | Unknown |
| Negative Serum Control | 404577 | FDA UDI | Class II | Unknown |
| Negative Control | 403593 | FDA UDI | Class II | Unknown |
| Conjugate Concentrate | 628212 | FDA UDI | U | Active |
| PakAuto® | PAKAUTO-MAYO | FDA UDI | Class II | Unknown |
| ThromboType® | THROMBOTYPE | FDA UDI | Class II | Unknown |
| DonorScreen-HLA® Class I and Class II Additional Reagents | 303456 | FDA UDI | U | Active |
| LIFECODES Class I ID Typing Kit for use with Luminex | 628200 | FDA UDI | U | Active |
| Kit Control | 403591 | FDA UDI | Class II | Unknown |
| LIFECODES® B-Screen® | BCSG | FDA UDI | Class II | Unknown |
| Normal Platelet Control (Negative Eluate Control) | 404578 | FDA UDI | Class II | Unknown |
| Negative Serum Control | 404573 | FDA UDI | Class II | Unknown |
| PF4 IgG | HAT13G | FDA UDI | Class II | Active |
| Negative Serum Control | 404574 | FDA UDI | Class II | Unknown |
| Positive Control Serum | 403892 | FDA UDI | U | Unknown |
| Factor VIII Antibody Screen | F8S | FDA UDI | Class II | Active |
| PNPP Substrate | 403594 | FDA UDI | Class II | Unknown |
| Anti-Human IgG/A/M Conjugate | 404588 | FDA UDI | Class II | Unknown |
| LIFECODES HLA-B eRES SSO Typing Kit for use with Luminex | 628917 | FDA UDI | U | Active |
| Concentrated Wash (10X) | 404562 | FDA UDI | Class II | Unknown |
| LIFECODES LifeScreen XP | 628220 | FDA UDI | U | Active |
| PF4 IgG | HAT45G | FDA UDI | Class II | Active |
| Dilution Solution | 628515 | FDA UDI | U | Active |
| Specimen Diluent | 403831 | FDA UDI | Class II | Unknown |
| LIFECODES LifeScreen Deluxe | 628215 | FDA UDI | U | Active |
| PakAuto® | PAKAUTO | FDA UDI | Class II | Unknown |
| Positive Control | 403596 | FDA UDI | Class II | Unknown |
| LIFECODES® QuikScreen® | QS12G | FDA UDI | U | Unknown |
| LIFECODES HLA-A SSO Typing Kit | 628911 | FDA UDI | U | Unknown |
| Negative Serum Control | 404576 | FDA UDI | Class II | Unknown |
| PakPlus® | PAKPLUS | FDA UDI | Class II | Active |
| Anti-Human IgG Conjugate | 404558 | FDA UDI | Class II | Unknown |
| Substrate Buffer | 404587 | FDA UDI | Class II | Unknown |
| Buffering Solution | 404560 | FDA UDI | Class II | Unknown |
| LIFECODES MATCH IT! Antibody Software | 888627 | FDA UDI | U | Active |
| Stopping Solution | 404585 | FDA UDI | Class II | Unknown |
| LIFECODES MATCH IT!™ DNA Software v1.3 | 888623 | FDA UDI | U | Active |
| LIFECODES LSA Class II | 265200IVD | FDA UDI | U | Active |
| LIFECODES HLA-DPA1/B1 SSO Typing Kit for use with Luminex | 628936 | FDA UDI | U | Active |
| Positive Control Serum | 628213 | FDA UDI | U | Unknown |
| PF4 Enhanced® | X-HAT13 | FDA UDI | Class II | Active |
| LIFECODES HLA-A eRES SSO Typing Kit for use with Luminex | 628913 | FDA UDI | U | Active |
Related Companies
Authorised Representatives
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.