FDA Registration
Active
🇨🇦 Canada
BIOMEDICA DIAGNOSTICS INC.
Reg #: 3003691680
·
FEI: 3003691680
·
Expires 2026
Products
11
Proprietary Names
21
Establishment Types
1
Classifications
11
Registration Details
- Registration Name
- BIOMEDICA DIAGNOSTICS INC.
- Registration Number
- 3003691680
- FEI Number
- 3003691680
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 94 Wentworth Road
- City
- Windsor Nova Scotia
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K052124
Owner / Operator
- Firm Name
- BioMedica Diagnostics Inc.
- Operator Number
- 9050020
- Address
- 94 Wentworth Road
- City
- Windsor
- State
- Nova Scotia
- Postal Code
- B0N 2T0
- Country
- CA
- Correspondent
- Daniel Moreno
US Agent
- Business Name
- BIOMEDICA DIAGNOSTICS INC
- Contact Name
- David Teicher
- Address
- 24 Deer Tree Ln
- City
- Briarcliff Manor
- State
- NY
- ZIP
- 10510
- Country
- US
- [email protected]
- Phone
- 914 4844146
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Test, Time, Prothrombin | GJS | Class 2 | Hematology | No | 2016-12-19 |
| Test, Qualitative And Quantitative Factor Deficiency | GGP | Class 2 | Hematology | No | 2016-12-19 |
| Activated Partial Thromboplastin | GFO | Class 2 | Hematology | No | 2002-04-03 |
| Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | DAP | Class 2 | Hematology | No | 2016-12-20 |
| Assay, Heparin | KFF | Class 2 | Hematology | No | 2016-12-20 |
| Plasma, Coagulation Control | GGN | Class 2 | Hematology | No | 2016-12-19 |
| Antithrombin Iii Quantitation | JBQ | Class 2 | Hematology | No | 2016-12-19 |
| Reagent, Russel Viper Venom | GIR | Class 1 | Hematology | No | 2016-12-19 |
| Test, Time, Partial Thromboplastin | GGW | Class 2 | Hematology | No | 2016-12-20 |
| Plasma, Control, Normal | GIZ | Class 2 | Hematology | No | 2016-12-21 |
| Control, Plasma, Abnormal | GGC | Class 2 | Hematology | No | 2016-12-21 |
Proprietary Names
ACTICLOT dPT
IMUBIND vWF Activity ELISA
QuickCoag APTT-EA
ACTICLOT Protein S
IMUBIND Plasma PAI-1 ELISA
DIMERTEST Latex
ACTICHROME Heparin (Anti-FXa)
ACTICLOT Activated Protein C Resistance Control Plasma
QuickCoag Low Abnormal Control Level 2
QuickCoag High Abnormal Control Level 3
QuickCoag Normal Control Level 1
ACTICHROME AT III
QuickCoag PT-HS
DVV confirm 10
DVVtest 10
DVV confirm 5
ACTICLOT C
SPECTROLYSE PAI-1
ACTICHROME Heparin (Anti-FIIa)
LAtrol Abnormal Control Plasma
LAtrol Normal Control Plasma
Establishment Types
Manufacture Medical Device