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Sign in to claim this brandR2 DIAGNOSTICS, INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 1801 COMMERCE DR., SOUTH BEND, IN, 46628
- Website
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- —
- —
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- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 3000210416
- DUNS Number
- —
Catalogue (22)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PlasmaCon LA | 150-200 | FDA UDI | Class II | Active |
| FIB Calibrator | 71-201 | FDA UDI | Class II | Active |
| Fibrotek | 70-410 | EUDAMEDFDA UDI | Class II | Active |
| PlasmaRef ARN | 33-201 | FDA UDI | Class II | Active |
| PlasmaCon LA | 150-201 | FDA UDI | Class II | Active |
| PlasmaCon N | 30-201 | FDA UDI | Class II | Active |
| LupoTek Detectin VL | 85-202 | EUDAMEDFDA UDI | Class I | Active |
| LupoTek KCT | 87-305 | FDA UDI | Class II | Active |
| PlasmaRef ARL-2 | 35-201 | FDA UDI | Class II | Active |
| ThromboTek PSe | 90-480 | EUDAMEDFDA UDI | Class II | Active |
| PlasmaCon L2 | 32-201 | FDA UDI | Class II | Active |
| Phospholin ES w/ Calcium Chloride | 21-410 | EUDAMEDFDA UDI | Class II | Active |
| Thrombo Tek Pse, Model 90-480 | K082631 | FDA 510(k) | Class II | Active |
| Lupotek Correctin Vl, Lupotek Detectin Vl, Plasmacon La | K083878 | EUDAMEDFDA 510(k)FDA UDI | Class I | Active |
| Nofact Viii | K102851 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| T-Tek | K050817 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Fibrotek Fib | K042919 | FDA 510(k) | Class II | Active |
| Plasmacon N, Plasmacon L-1, Plasmacon L-2 | K062306 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Nofact Ix | K102908 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
| Phospholin Es And Calcium Chloride | K033471 | FDA 510(k) | Class II | Active |
| Lupotek Kct | K090105 | FDA 510(k) | Class II | Active |
| Phosphoplastin Rl | K040296 | EUDAMEDFDA 510(k)FDA UDI | Class II | Active |
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