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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 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Capture-R Ready-ID Extend I | 0006455 | FDA UDI | N/A | Active |
| Capture-R Ready Indicator Red Cells | 0066907 | FDA UDI | Class II | Active |
| corQC EXTEND 1, 2, and 3 | 0002417 | FDA UDI | Class II | Active |
| Anti-IgG (Murine Monoclonal) (Green) Gamma-clone | 0409210 | FDA UDI | N/A | Active |
| Capture-R Ready Indicator Red Cells | 0006427 | FDA UDI | Class II | Active |
| Capture-R Ready-ID | 0066214 | FDA UDI | N/A | Active |
| Gamma N-HANCE | 0705410 | FDA UDI | Class II | Active |
| Anti-S | 0007454 | FDA UDI | N/A | Active |
| Anti-k | 0007537 | FDA UDI | N/A | Active |
| Weak D Cells | 0002995 | FDA UDI | Class II | Active |
| Capture-R Ready-Screen (3) | 0066816 | FDA UDI | Class II | Active |
| Referencells A1 and B | 0002345 | FDA UDI | N/A | Active |
| Checkcell | 0002224 | FDA UDI | Class II | Active |
| DAT Positive Control Cell | 0066125 | FDA UDI | Class II | Active |
| Anti-D Series 4 (Murine Monoclonal) | 0006413 | FDA UDI | N/A | Active |
| Anti-K (Human Monoclonal) Series 2 | 0004210 | FDA UDI | N/A | Active |
| corQC EXTEND Standard | 0066296 | FDA UDI | Class II | Active |
| Anti-B (Murine Monoclonal) Gamma-clone | 0413210 | FDA UDI | N/A | Active |
| Gamma LO-ION | 0704610 | FDA UDI | Class II | Active |
| Capture LISS | 0006420 | FDA UDI | Class I | Active |
| Anti-s | 0007457 | FDA UDI | N/A | Active |
| Anti-K (Monoclonal) Gamma-clone | 0066451 | FDA UDI | N/A | Active |
| Capture-R® Ready-Screen® (I and II) | 0066202 | FDA UDI | N/A | Active |
| Anti-c (Monoclonal) Gamma-clone | 0066425 | FDA UDI | N/A | Active |
| Capture-R Ready-ID | 0066204 | FDA UDI | N/A | Active |
| Capture-R Positive Control Serum (Weak), Capture-R Negative Control Serum | 0066902 | FDA UDI | Class I | Active |
| Anti-A, B (Murine Monoclonal) Gamma-clone Series 2 | 0414210 | FDA UDI | N/A | Active |
| Capture-R Ready-Screen (Pooled Cells) | 0006436 | FDA UDI | N/A | Active |
| Capture-R Ready-Screen (Pooled Cells) | 0066254 | FDA UDI | N/A | Active |
| Capture-R Ready-Screen (I and II) | 0006440 | FDA UDI | N/A | Active |
| Panocell-16 | 0002332 | FDA UDI | N/A | Active |
| Capture-R Ready-Screen (4) | 0066812 | FDA UDI | N/A | Active |
| Anti-D (Monoclonal Blend) Gamma-clone | 0420503 | FDA UDI | N/A | Active |
| Anti-Fya | 0007591 | FDA UDI | N/A | Active |
| Anti-B (Murine Monoclonal) Gamma-clone | 0413203 | FDA UDI | N/A | Active |
| Anti-Fyb (Monoclonal) Gamma-clone | 0004818 | FDA UDI | N/A | Active |
| Monoclonal Control | 0066087 | FDA UDI | Class II | Active |
| Capture-CMV Control set | 0066239 | FDA UDI | Class II | Active |
| Capture-R Ready-Screen (Pooled Cells) | 0066213 | FDA UDI | N/A | Active |
| Anti-A, B (Murine Monoclonal Blend) Series 1 | 0006408 | FDA UDI | N/A | Active |
| Checkcell (Weak) | 0002227 | FDA UDI | Class II | Active |
| Capture-P Indicator Red Cells | 0066240 | FDA UDI | Class I | Active |
| Capture-R Ready-Screen (Pooled Cells) | 0066203 | FDA UDI | N/A | Active |
| Anti-D (Monoclonal Blend) Series 4 | 0006412 | FDA UDI | N/A | Active |
| Panocell-10, Ficin-Treated | 0002385 | FDA UDI | N/A | Active |
| Capture-R Ready-Screen 3 | 0066901 | FDA UDI | U | Active |
| Anti-K | 0004140 | FDA UDI | N/A | Active |
| Panocell-10 | 0003032 | FDA UDI | N/A | Active |
| WB corQC | 0066090 | FDA UDI | Class II | Active |
| Capture-R Ready-Screen (3) | 0066814 | FDA UDI | N/A | Active |
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