FDA Registration
Active
🇨🇦 Canada
DIAGNOSTICS BIOCHEM CANADA, INC.
Reg #: 8010132
·
FEI: 3002806808
·
Expires 2026
Products
16
Proprietary Names
20
Establishment Types
1
Classifications
16
Registration Details
- Registration Name
- DIAGNOSTICS BIOCHEM CANADA, INC.
- Registration Number
- 8010132
- FEI Number
- 3002806808
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 384 Neptune Crescent
- City
- London Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K014120
Owner / Operator
- Firm Name
- DIAGNOSTICS BIOCHEM CANADA, INC.
- Operator Number
- 8010132
- Address
- 384 Neptune Crescent
- City
- London
- State
- Ontario
- Postal Code
- N6M 1A1
- Country
- CA
- Correspondent
- Manon - Hogue
US Agent
- Business Name
- Regulatory Insight Inc.
- Contact Name
- Kevin Walls
- Address
- 33 Golden Eagle Lane
- City
- Littleton
- State
- CO
- ZIP
- 80127
- Country
- US
- [email protected]
- Phone
- 720 9625412
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Glucagon | JME | Class 1 | Clinical Chemistry | No | 2024-10-08 |
| Radioimmunoassay, Androstenedione | CIZ | Class 1 | Clinical Chemistry | No | 1977-12-09 |
| Radioimmunoassay, Testosterones And Dihydrotestosterone | CDZ | Class 1 | Clinical Chemistry | No | 2007-11-20 |
| Radioimmunoassay, 17-Hydroxyprogesterone | JLX | Class 1 | Clinical Chemistry | No | 2009-05-04 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 1977-12-09 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2003-01-06 |
| Radioimmunoassay, Estrone | CGF | Class 1 | Clinical Chemistry | No | 2003-01-06 |
| Radioimmunoassay, Total Triiodothyronine | CDP | Class 2 | Clinical Chemistry | No | 1977-12-09 |
| Radioimmunoassay, Human Growth Hormone | CFL | Class 1 | Clinical Chemistry | No | 1977-12-09 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 1977-12-09 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 1977-12-09 |
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 1977-12-09 |
| Radioimmunoassay, Estriol | CGI | Class 1 | Clinical Chemistry | No | 1977-12-09 |
| Radioimmunoassay, Pregnenolone | JNG | Class 1 | Clinical Chemistry | No | 2003-01-06 |
| Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | JKC | Class 1 | Clinical Chemistry | No | 2003-01-06 |
| Radioimmunoassay, Total Estrogens, Nonpregnancy | JMD | Class 1 | Clinical Chemistry | No | 1977-12-09 |
Proprietary Names
Glucagon ELISA (CAN-GLN-390)
Androstenedione ELISA (CAN-AD-208)
Testosterone (TE) ELISA (CAN-TE-250)
17?-Hydroxyprogesterone (17?-OHP) ELISA (CAN-P-400)
17?-Hydroxyprogesterone (17?-OHP) ELISA (CAN-P-320)
17?-Hydroxyprogesterone (17?-OHP) ELISA (CAN-P-540)
Luteinizing Hormone (hLH) ELISA (CAN-LH-4040)
Prolactin (PRL) ELISA (CAN-PRL-4100)
Estrone ELISA (CAN-E-420, CAN-E-420-8PK)
Triiodothyronine (T3) ELISA (CAN-T3-4220)
Growth Hormone (hGH) ELISA (CAN-GH-4070)
Progesterone ELISA (CAN-P-305)
Follicle Stimulating Hormone (hFSH) ELISA (CAN-FSH-4060)
Estradiol ELISA (CAN-E-430)
Free Estriol ELISA (CAN-E-640)
Free Testosterone (fTE) ELISA (CAN-FTE-260, CAN-FTE-260LC8)
Pregnenolone ELISA (CAN-PRE-4500)
Dehydroepiandrosterone Sulfate (DHEAS) ELISA (CAN-DHS-480)
Dehydroepiandrosterone (DHEA) ELISA (CAN-DH-490)
Total Estrogens ELISA (CAN-E-630, CAN-E-630-4PK, CAN-E-630-8PK)
Establishment Types
Manufacture Medical Device