FDA Registration
Active
🇨🇳 China
Progesterone (PdG) Rapid Test
Reg #: 3016630443
·
FEI: 3016630443
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
6
Classifications
1
Registration Details
- Registration Name
- Eugene Biotech Co., Ltd.
- Registration Number
- 3016630443
- FEI Number
- 3016630443
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Build 1, Runcai Intelligent Industrial Park, No.1666 XinYang Road, Fengxian District
- City
- Shanghai
- Country
- CN
Owner / Operator
- Firm Name
- BioMediCore Inc.
- Operator Number
- 10064231
- Address
- 352 Forest View Dr
- City
- South San Francisco
- State
- CA
- Postal Code
- 94080
- Country
- US
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Immunoassay, Pregnanediol Glucuronide, Over The Counter | QKE | Class 1 | Clinical Chemistry | No | 2020-03-24 |
Proprietary Names
Progesterone (PdG) Rapid Test
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Remanufacture Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)