FDA Registration
Active
🇺🇸 United States
GERMAINE LABORATORIES, INC.
Reg #: 1649661
·
FEI: 3001451797
·
Expires 2025
Products
12
Proprietary Names
0
Establishment Types
2
Classifications
12
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
- K111221
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 |
|---|---|---|---|---|---|
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | Class 2 | Clinical Chemistry | No | 2016-04-26 |
| Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | NGJ | Class 1 | Clinical Chemistry | No | 2016-04-26 |
| Blood, Occult, Colorimetric, In Urine | JIO | Class 2 | Hematology | No | 2016-04-26 |
| Test, Urine Leukocyte | LJX | Class 1 | Hematology | No | 2016-04-26 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | Class 1 | Clinical Chemistry | No | 2016-04-26 |
| Refractometer For Clinical Use | JRE | Class 1 | Clinical Chemistry | No | 2016-04-26 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | Class 1 | Clinical Chemistry | No | 2016-04-26 |
| Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric) | JMA | Class 1 | Clinical Chemistry | No | 2016-04-26 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | Class 1 | Clinical Chemistry | No | 2016-04-26 |
| Automated Urinalysis System | KQO | Class 1 | Clinical Chemistry | No | 2016-04-26 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | Class 1 | Clinical Chemistry | No | 2016-04-26 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | Class 1 | Clinical Chemistry | No | 2016-04-26 |
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device