FDA Registration
Active
🇺🇸 United States
Anti TG Ab ELISA, EIA-3708
Reg #: 2245285
·
FEI: 2245285
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- DRG International, Inc.
- Registration Number
- 2245285
- FEI Number
- 2245285
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 841 Mountain Ave
- City
- Springfield
- State
- NJ
- ZIP
- 07081
- Country
- US
Regulatory Submissions
- 510(k) Number
- K952130
Owner / Operator
- Firm Name
- BIOCHECK, INC.
- Operator Number
- 9033543
- Address
- 425 Eccles Avenue, --
- City
- South San Francisco
- State
- CA
- Postal Code
- 94080
- Country
- US
- Correspondent
- Johanna - Saito
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Test, Thyroid Autoantibody | JZO | Class 2 | Immunology | No | 2022-12-15 |
Proprietary Names
Anti TG Ab ELISA, EIA-3708
Establishment Types
Repack or Relabel Medical Device