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US
Last updated May 23, 2026
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Catalogue (72)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PAP-8E Software CD | 107153 | FDA UDI | Class II | Active |
| Adp | 101312 | FDA UDI | Class II | Active |
| Arachidonic Acid | 101297 | FDA UDI | Class II | Active |
| vW Normal Reference Plasma | 101269 | FDA UDI | Class II | Active |
| Stir Bars, Micro | 105990 | FDA UDI | Class I | Active |
| LTA Check Test Kit | 107117 | FDA UDI | Class I | Active |
| Sample Tubes | 106853 | FDA UDI | Class I | Active |
| MagneTube | 107146 | FDA UDI | Class I | Active |
| Platelet Aggregometer Profiler | PAP8E | FDA UDI | Class II | Active |
| PDQ Platelet Centrifuge | 106842 | FDA UDI | Class I | Active |
| Stir Bars, Macro | 105977 | FDA UDI | Class I | Active |
| AggRecetin | Bulk 100mg | FDA UDI | Class II | Active |
| Par/Pak Ii | 101310 | FDA UDI | Class II | Active |
| vW Normal Control Plasma | 106426 | FDA UDI | Class II | Active |
| Profiler Paper | 101375 | FDA UDI | Class I | Active |
| Lyophilized Platelets | 3 X 4.0 mL | FDA UDI | Class II | Active |
| Sodium Citrate | 100994 | FDA UDI | Class II | Active |
| Tris Buffered Saline | 100991 | FDA UDI | Class II | Active |
| Test Tubes, Macro | 100336 | FDA UDI | Class I | Active |
| vW Factor Assay (Ristocetin Cofactor) | 103025 | FDA UDI | Class II | Active |
| Transfer Pipettes, Disposable | 106852 | FDA UDI | Class I | Active |
| Lyophilized Platelets | 10mL | FDA UDI | Class II | Active |
| Sample Tube Caps | 106899 | FDA UDI | Class I | Active |
| AggRecetin | 1.0-1.5 mg/mL | FDA UDI | Class II | Active |
| Calcium Chloride | 100989 | FDA UDI | Class II | Active |
| Collagen | Calf Skin Type 1 | FDA UDI | Class II | Active |
| Printer Paper | 105598 | FDA UDI | Class I | Active |
| Test Tubes, Micro | 101521 | FDA UDI | Class I | Active |
| AGG/PAK 5 Combo Kit | 107650 | FDA UDI | Class II | Active |
| Lupus Anticoagulant Confirmation Reagent | 102516 | FDA UDI | Class II | Active |
| Epinephrine | 101311 | FDA UDI | Class II | Active |
| vW Select Kit (Ristocetin Cofactor) | 106730 | FDA UDI | Class II | Active |
| Platelet Aggregometer Profiler | PAP-8E | FDA UDI | Class II | Active |
| LTA Check CD | 107149 | FDA UDI | Class I | Active |
| vW Abnormal Control Plasma | 101270 | EUDAMEDFDA UDI | Class II | Active |
| Barbital Saline Buffer | K761170 | FDA 510(k) | Class I | Active |
| Thrombin Clotting Time | K811109 | FDA 510(k) | Class II | Active |
| Arachidonic Acid | K811290 | FDA 510(k) | Class II | Active |
| Beta/Pak | K790769 | FDA 510(k)FDA UDI | Class II | Active |
| Aggrecetin | K760893 | FDA 510(k) | Class II | Active |
| Imidazole Buffer (0.05m) | K761175 | FDA 510(k) | Class II | Active |
| Thrombokinetic Fibrinogen Assay | K792563 | FDA 510(k) | Class II | Active |
| Microsample Coagulation Analyser Model 110p | K854546 | FDA 510(k) | Class II | Active |
| Thrombinex Bovine Thrombin | K845000 | FDA 510(k) | Class II | Active |
| Von Willebrand Factor Assay | K802356 | FDA 510(k) | Class II | Active |
| Platelet Aggregation Profiler Model Pap-4c | K893650 | FDA 510(k) | Class II | Active |
| Calcium Chloride | K853246 | FDA 510(k) | Class II | Active |
| Microsample Coagulation Analyzer, Model Mca 310-C | K001891 | FDA 510(k) | Class II | Active |
| Citrex H | K853897 | FDA 510(k) | Class II | Active |
| Calcium Chloride (0.025m) | K761176 | FDA 510(k) | Class II | Active |
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