FDA Registration
Active
🇺🇸 United States
Bialex Glucose Oxidase
Reg #: 3021841051
·
FEI: 3021841051
·
Expires 2025
Products
6
Proprietary Names
2
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- BIALEX LAB
- Registration Number
- 3021841051
- FEI Number
- 3021841051
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 717 Ohio Ave
- City
- Wichita Falls
- State
- TX
- ZIP
- 76301
- Country
- US
Regulatory Submissions
- 510(k) Number
- K070017
Owner / Operator
- Firm Name
- Bialex Lab
- Operator Number
- 10049801
- Address
- 717 Ohio Ave
- City
- Wichita Falls
- State
- TX
- Postal Code
- 76301
- Country
- US
- Correspondent
- Carlos H Quine
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lipoprotein, High Density, Hdl, Over The Counter | NAQ | Class 1 | Clinical Chemistry | No | 2015-09-14 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2015-09-14 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2015-09-14 |
| Colorimetric Method, Triglycerides | JGY | Class 1 | Clinical Chemistry | No | 2015-09-14 |
| Ldl & Vldl Precipitation, Hdl | LBR | Class 1 | Clinical Chemistry | No | 2015-09-14 |
| Test, Triglycerides, Over The Counter | NGO | Class 1 | Clinical Chemistry | No | 2015-09-14 |
Proprietary Names
Bialex Glucose Oxidase
Bialex Triglycerides
Establishment Types
Manufacture Medical Device