FDA Registration
Active
🇺🇸 United States
GERMAINE LABORATORIES, INC.
Reg #: 1649661
·
FEI: 3001451797
·
Expires 2025
Products
6
Proprietary Names
0
Establishment Types
2
Classifications
6
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
- K130295
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 |
|---|---|---|---|---|---|
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2019-11-04 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2019-11-04 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | Class 1 | Clinical Chemistry | No | 2019-11-04 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2019-11-04 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2019-11-04 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2019-11-04 |
Establishment Types
Manufacture Medical Device
Remanufacture Medical Device