FDA Registration
Active
🇺🇸 United States
Calibrator, secondary 3014233026 Foreign Exporter
Reg #: 3009518015
·
FEI: 3009518015
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
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
- K033603
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 |
|---|---|---|---|---|---|
| Calibrator, Secondary | JIT | Class 2 | Clinical Chemistry | No | 2024-12-19 |
| Radioassay, Intrinsic Factor Blocking Antibody | LIG | Class 2 | Clinical Chemistry | No | 2024-12-19 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2024-12-19 |
Proprietary Names
Calibrator, secondary 3014233026 Foreign Exporter
Single (specified) analyte controls (assayed and unassayed)
RADIOASSAY, INTRINSIC FACTOR BLOCKING ANTIBODY
Establishment Types
Repack or Relabel Medical Device