Data / Medical devices / Canada / Biomedica Diagnostics Inc.
Biomedica Diagnostics Inc.: FDA-registered device maker in Windsor Nova Scotia, Canada, 17 510(k) clearances
Biomedica Diagnostics Inc. is registered with the FDA (registration 3003691680) in Windsor Nova Scotia, Canada. It lists 11 device types. The FDA files 17 510(k) clearances under its listings, the newest dated February 13, 2008. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3003691680
- Address
- 94 Wentworth Road, Windsor Nova Scotia, Canada, B0N 2T0
- Owner or operator
- BioMedica Diagnostics Inc. (9050020)
- Roles
- Manufacturer
- First device listed
- April 3, 2002
- Registered through
- 2026
- Brand names listed
- ACTICHROME AT III, ACTICHROME Heparin (Anti-FIIa), ACTICHROME Heparin (Anti-FXa), ACTICLOT Activated Protein C Resistance Control Plasma, ACTICLOT C, ACTICLOT Protein S, ACTICLOT dPT, DIMERTEST Latex and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activated Partial Thromboplastin | GFO | 2 | Manufacturer | accessdata.fda.gov |
| Antithrombin Iii Quantitation | JBQ | 2 | Manufacturer | accessdata.fda.gov |
| Assay, Heparin | KFF | 2 | Manufacturer | accessdata.fda.gov |
| Control, Plasma, Abnormal | GGC | 2 | Manufacturer | accessdata.fda.gov |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Coagulation Control | GGN | 2 | Manufacturer | accessdata.fda.gov |
| Plasma, Control, Normal | GIZ | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Russel Viper Venom | GIR | 1 | Manufacturer | accessdata.fda.gov |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | 2 | Manufacturer | accessdata.fda.gov |
| Test, Time, Partial Thromboplastin | GGW | 2 | Manufacturer | accessdata.fda.gov |
| Test, Time, Prothrombin | GJS | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2008 | K080069 | DIMERTEST | DAP | Substantially Equivalent | American Diagnostica, Inc. | accessdata.fda.gov |
| August 15, 2007 | K063323 | SPECTROLYSE PAI-1, MODEL 101201 | GGP | Substantially Equivalent | American Diagnostica, Inc. | accessdata.fda.gov |
| October 17, 2005 | K052124 | ACTICLOT, MODEL 824 | GJS | Substantially Equivalent | American Diagnostica, Inc. | accessdata.fda.gov |
| December 22, 2004 | K042762 | PEFAKIT APC-R FACTOR V LEIDEN | GGW | Substantially Equivalent | Pentapharm , Ltd. | accessdata.fda.gov |
| December 22, 2004 | K042760 | PEFAKIT APC-R FACTOR V LEIDEN CONTROLS | GGN | Substantially Equivalent | Pentapharm , Ltd. | accessdata.fda.gov |
| November 1, 2002 | K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | GFO | Substantially Equivalent | Vital Scientific N.V. | accessdata.fda.gov |
| July 23, 2002 | K022046 | VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL | GGN | Substantially Equivalent | Vital Scientific N.V. | accessdata.fda.gov |
| May 15, 2002 | K020840 | VITAL SCIENTIFIC PT WITH CALCIUM | GJS | Substantially Equivalent | Vital Scientific N.V. | accessdata.fda.gov |
| April 16, 2002 | K013637 | ACTICHROME HEPARIN (ANTI-FIIA) | KFF | Substantially Equivalent | American Diagnostica, Inc. | accessdata.fda.gov |
| March 8, 2002 | K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | KFF | Substantially Equivalent | American Diagnostica, Inc. | accessdata.fda.gov |
| March 7, 2002 | K013168 | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 | GGP | Substantially Equivalent | American Diagnostica, Inc. | accessdata.fda.gov |
| September 14, 2001 | K012386 | ACTICLOT PROTEIN S, MODEL 843L | GGP | Substantially Equivalent | American Diagnostica, Inc. | accessdata.fda.gov |
| April 17, 2000 | K000398 | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 | GGP | Substantially Equivalent | Shield Diagnostics, Ltd. | accessdata.fda.gov |
| April 5, 1995 | K940490 | DV TEST AND DVV CONFIRM | GIR | Substantially Equivalent | American Diagnostica, Inc. | accessdata.fda.gov |
| September 19, 1994 | K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | GIZ | Substantially Equivalent | American Diagnostica, Inc. | accessdata.fda.gov |
| June 23, 1989 | K893608 | ACTICHROME ATIII KIT | JBQ | Substantially Equivalent | American Diagnostic Corp. | accessdata.fda.gov |
| March 13, 1989 | K884941 | ACTICLOT C KIT | GGP | Substantially Equivalent | American Diagnostic Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Test, Time, Prothrombin
- All makers of Assay, Heparin
- All makers of Test, Time, Partial Thromboplastin
- All makers of Plasma, Coagulation Control
- All makers of Antithrombin Iii Quantitation
- All makers of Test, Qualitative And Quantitative Factor Deficiency
Updated February 13, 2008. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.