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United States·US-MF-000011568
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 3130, Gateway Drive, Norcross, United States
- —
- —
- [email protected]
- Phone
- +1 770 441 2051
- PRRC Contact
- Charnelle Thomas
- EUDAMED SRN
- US-MF-000011568
- FDA FEI Number
- 1034569
- DUNS Number
- 061446282
Catalogue (181)
Page 3 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Galileo Neo | 0064599 | FDA UDI | Class II | Active |
| Anti-IgG, -C3d (Polyspecific) (Murine Monoclonal) (Green) Gamma-clone | 0409710 | FDA UDI | N/A | Active |
| Capture-CMV | 0066216 | FDA UDI | Class II | Active |
| Capture-CMV Indicator Red Cells | 0066238 | FDA UDI | Class II | Active |
| Gamma-Quin | 0007890 | FDA UDI | Class II | Active |
| Monoclonal Control | 0066089 | FDA UDI | Class II | Active |
| Capture-R Ready-Screen (3) | 0066804 | FDA UDI | N/A | Active |
| Anti-Fya (Monoclonal) Gamma-clone | 0004816 | FDA UDI | N/A | Active |
| TPHA Screen Diluent | 0066827 | FDA UDI | Class II | Active |
| Referencells | 0066900 | FDA UDI | U | Active |
| Anti-A (Murine Monoclonal) Gamma-clone | 0410203 | FDA UDI | N/A | Active |
| Capture LISS | 0066908 | FDA UDI | Class I | Active |
| Panoscreen I, II, and III | 0002381 | FDA UDI | N/A | Active |
| Di(a+) Cell | 0005021 | FDA UDI | N/A | Active |
| Capture-P Ready-Screen | 0066247 | FDA UDI | Class I | Active |
| Anti-B (Murine Monoclonal) Series 3 | 0006407 | FDA UDI | N/A | Active |
| Anti-s (Monoclonal) Gamma-clone | 0066429 | FDA UDI | N/A | Active |
| Anti-S (Monoclonal) Gamma-clone | 0004814 | FDA UDI | N/A | Active |
| Referencells A2 | 0002342 | FDA UDI | N/A | Active |
| Anti-S (Monoclonal) Gamma-clone | 0066428 | FDA UDI | N/A | Active |
| Anti-IgG (Murine Monoclonal) (Green) Gamma-clone | 0409203 | FDA UDI | N/A | Active |
| Gamma PeG | 0705010 | FDA UDI | Class II | Active |
| Anti-Dia | 0007620 | FDA UDI | N/A | Active |
| Capture-P Positive Control Serum (Weak), Capture-P Negative Control Serum | 0066905 | FDA UDI | Class I | Active |
| Capture-R Ready-Screen (3) | 0066803 | FDA UDI | N/A | Active |
| Anti-H (Ulex europaeus) | 0007151 | FDA UDI | Class II | Active |
| Gamma N-HANCE | 0705403 | FDA UDI | Class II | Active |
| Anti-Jkb | 0007604 | FDA UDI | N/A | Active |
| Anti-s (Monoclonal) Gamma-clone | 0004815 | FDA UDI | N/A | Active |
| Anti-D (Monoclonal Blend) Series 5 | 0006414 | FDA UDI | N/A | Active |
| Capture-R Ready Indicator Red Cells | 0006428 | FDA UDI | Class II | Active |
| Capture LISS | 0066231 | FDA UDI | Class I | Active |
| Capture-R Ready-Screen (3) | 0066815 | FDA UDI | N/A | Active |
| Anti-C (Monoclonal) Gamma-clone | 0066421 | FDA UDI | N/A | Active |
| Anti-Jka | 0007601 | FDA UDI | N/A | Active |
| Capture-R Ready-Screen (4) | 0066802 | FDA UDI | N/A | Active |
| Bovine Albumin Solution 22% | 0002327 | FDA UDI | Class II | Active |
| TPHA Screen | 0066826 | FDA UDI | Class II | Active |
| Panoscreen I, II, and III | 0002377 | FDA UDI | N/A | Active |
| corQC EXTEND Complete | 0066297 | FDA UDI | Class II | Active |
| Anti-M (Murine Monoclonal) Gamma-clone | 0004802 | FDA UDI | N/A | Active |
| Capture-R Ready-ID Extend II | 0006457 | FDA UDI | N/A | Active |
| Capture LISS | 0006418 | FDA UDI | Class I | Active |
| Capture-R Ready-Screen (Pooled Cells) | 0006433 | FDA UDI | N/A | Active |
| Anti-IgG, -C3d (Polyspecific) (Murine Monoclonal) (Uncolored) Gamma-clone | 0401010 | FDA UDI | N/A | Active |
| Panocell-20 | 0005020 | FDA UDI | N/A | Active |
| Capture-R Select | 0006446 | FDA UDI | Class II | Active |
| Checkcell (Weak) | 0002226 | FDA UDI | Class II | Active |
| Panoscreen EXTEND | 0002383 | FDA UDI | U | Active |
| Capture-R Ready-ID Extend II | 0006456 | FDA UDI | N/A | Active |
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