FDA Registration
Active
🇺🇸 United States
AimStep H. Pylori
Reg #: 1649661
·
FEI: 3001451797
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- GERMAINE LABORATORIES, INC.
- Registration Number
- 1649661
- FEI Number
- 3001451797
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 11030 Wye Drive
- City
- SAN ANTONIO
- State
- TX
- ZIP
- 78217
- Country
- US
Regulatory Submissions
- 510(k) Number
- K024360
Owner / Operator
- Firm Name
- GERMAINE LABORATORIES, INC.
- Operator Number
- 9031523
- Address
- 11030 Wye Drive
- City
- San Antonio
- State
- TX
- Postal Code
- 78217
- Country
- US
- Correspondent
- Craig A Waldrip
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Helicobacter Pylori | LYR | Class 1 | Microbiology | No | 2020-03-19 |
Proprietary Names
AimStep H. Pylori
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device