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Sign in to claim this brandBiomedica, Inc.
US
Last updated May 23, 2026
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Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| DIMERTEST Latex assay | DLHK7 | FDA UDI | Class II | Active |
| Imubind Plasma Pai-1 Elisa | 822 | FDA UDI | Class II | Active |
| Acticlot C Kit | ACC-45 | FDA UDI | Class II | Active |
| ACTICLOT Protein C Resistance Kit | 840 | FDA UDI | Class II | Active |
| DVVtest 10 | 810 | FDA UDI | Class I | Active |
| Acticlot Protein S | 843L | FDA UDI | Class II | Active |
| LAtrol ABNORMAL CONTROL PLASMA | 816A | FDA UDI | Class II | Active |
| XL-FDP agglutination reagent | 800DB-LX | FDA UDI | Class II | Active |
| DVVconfirm 10 | 815L | FDA UDI | Class I | Active |
| Actichrome Heparin (anti-Fxa) | 832 | FDA UDI | Class II | Active |
| DVVtest 25 | 825 | FDA UDI | Class I | Active |
| IMUBIND vWF ACTIVITY ELISA | 885 | FDA UDI | Class II | Active |
| LAtrol NORMAL CONTROL PLASMA | 816N | FDA UDI | Class II | Active |
| Spectrolyse Pai-1 | 101201 | FDA UDI | Class II | Active |
| Actichrome Atiii Kit | 838 | FDA UDI | Class II | Active |
| Actiscreen Xl-Fdp | 800DB | FDA UDI | Class II | Active |
| DVVconfirm 5 | 815 | FDA UDI | Class I | Active |
| ACTICLOT Protein C Resistance control plasmas | 840C | FDA UDI | Class II | Active |
| ACTICLOT dPT | 824 | FDA UDI | Class II | Active |
| ACTICHROME Heparin (Anti-FIIa) | 820 | FDA UDI | Class II | Active |
| #2004 Phenylethyl Alchol Agar W/Sheep Bl | K820806 | FDA 510(k) | Class I | Active |
| #2006 Salmonella Shigella Agar | K820800 | FDA 510(k) | Class I | Active |
| #50001 Quade Diagnostic System | K820797 | FDA 510(k) | Class I | Active |
| #2005 Sabouraud Dextrose Agar/#4002 Sla | K820805 | FDA 510(k) | Class I | Active |
| #2011 Strep Selective Agar | K820807 | FDA 510(k) | Class I | Active |
| #4006 Tsb-Tubed Media | K820795 | FDA 510(k) | Class I | Active |
| #2007 Xld | K820801 | FDA 510(k) | Class I | Active |
| #1904l Mueller Hinton W/5% Sheep Blood | K820793 | FDA 510(k) | Class II | Active |
| #19041-150x15mm Mueller Hinton | K820792 | FDA 510(k) | Class II | Active |
| #4005 Tsa Slant-Tubed Media | K820791 | FDA 510(k) | Class I | Active |
| #2009 Biggy Agar | K820802 | FDA 510(k) | Class I | Active |
| #2013 Cna 5% Sheep Blood | K820804 | FDA 510(k) | Class I | Active |
| #2003 Mycobiotic Agar | K820803 | FDA 510(k) | Class I | Active |
| #2002 Mannitol Salt Agar | K820799 | FDA 510(k) | Class I | Active |
| #4004 Triple Sugar Iron Agar Slants-Tube | K820810 | FDA 510(k) | Class I | Active |
| #2008 Simmons Citrate | K820809 | FDA 510(k) | Class I | Active |
| #4001 Tubed Media - Fluid Thioglycollate | K820796 | FDA 510(k) | Class I | Active |
| #19012 Chocolate Mueller Hinton-150x15mm | K820794 | FDA 510(k) | Class II | Active |
| #2001 Hektoen | K820798 | FDA 510(k) | Class I | Active |
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