FDA Registration
Active
🇺🇸 United States
UniStrip Control Solution
Reg #: 3010622184
·
FEI: 3010622184
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- UNISTRIP TECHNOLOGIES, LLC
- Registration Number
- 3010622184
- FEI Number
- 3010622184
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 7224 Statesville Road, Suite A
- City
- Charlotte
- State
- NC
- ZIP
- 28269
- Country
- US
Regulatory Submissions
- 510(k) Number
- K160038
Owner / Operator
- Firm Name
- UniStrip Technologies, LLC
- Operator Number
- 10046018
- Address
- 7224 Statesville Road, Suite A
- City
- Charlotte
- State
- NC
- Postal Code
- 28269
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2018-10-08 |
| System, Test, Blood Glucose, Over The Counter | NBW | Class 2 | Clinical Chemistry | No | 2018-10-08 |
| Glucose Oxidase, Glucose | CGA | Class 2 | Clinical Chemistry | No | 2018-10-08 |
Proprietary Names
UniStrip Control Solution
Establishment Types
Complaint File Establishment per 21 CFR 820.198