FDA Registration
Active
🇺🇸 United States
SEEKER
Reg #: 3011240982
·
FEI: 3011240982
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- BAEBIES INC.
- Registration Number
- 3011240982
- FEI Number
- 3011240982
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 25 Alexandria Way
- City
- Durham
- State
- NC
- ZIP
- 27703
- Country
- US
Regulatory Submissions
- 510(k) Number
- DEN150035
Owner / Operator
- Firm Name
- BAE-B01
- Operator Number
- 10049734
- Address
- 25 Alexandria Way Durham, NC 27703 USA
- City
- Durham
- State
- NC
- Postal Code
- 27703
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Alpha-D-Galactosidase A (Gla) Newborn Screening Test System | PQW | Class 2 | Clinical Chemistry | No | 2017-05-10 |
| ß-Glucocerebrosidase (Gba) Newborn Screening Test System | PQV | Class 2 | Clinical Chemistry | No | 2017-05-10 |
| Alpha-L-Iduronidase (Idua) Newborn Screening Test System | PQT | Class 2 | Clinical Chemistry | No | 2017-05-10 |
| Alpha-D-Glucosidase (Gaa) Newborn Screening Test System | PQU | Class 2 | Clinical Chemistry | No | 2017-05-10 |
Proprietary Names
SEEKER
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device