FDA Registration
Active
🇺🇸 United States
ACID, FOLIC, RADIOIMMUNOASSAY
Reg #: 3009518015
·
FEI: 3009518015
·
Expires 2025
Products
5
Proprietary Names
5
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- 7051395 CANADA INC DBA HTA DIRECT SOURCING
- Registration Number
- 3009518015
- FEI Number
- 3009518015
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 102 West Service Road, Unit 047
- City
- Champlain
- State
- NY
- ZIP
- 12919
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140496
Owner / Operator
- Firm Name
- 7051395 Canada Inc Dba HTA Direct Sourcing
- Operator Number
- 10084602
- Address
- 102 West Service Road, Unit 1047
- City
- Champlain
- State
- NY
- Postal Code
- 12919
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2024-12-19 |
| Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | JJE | Class 1 | Clinical Chemistry | No | 2024-12-19 |
| Acid, Folic, Radioimmunoassay | CGN | Class 2 | Clinical Chemistry | No | 2024-12-19 |
| Radioassay, Vitamin B12 | CDD | Class 2 | Clinical Chemistry | No | 2024-12-19 |
| Ferritin, Antigen, Antiserum, Control | DBF | Class 2 | Immunology | No | 2024-12-19 |
Proprietary Names
ACID, FOLIC, RADIOIMMUNOASSAY
Radioassay, vitamin b12
RADIOIMMUNOASSAY, THYROID-STIMULATING HORMONE
ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE),FOR CLINICAL USE
Ferritin, antigen, antiserum, control
Establishment Types
Repack or Relabel Medical Device