UNISTRIP 1
UNISTRIP TECHNOLOGIES, LLC
UNISTRIP TECHNOLOGIES, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010622184 | 3010622184 | UNISTRIP TECHNOLOGIES, LLC | 1 | Y | 2026-01-01 | 11621 Patterson Road Suite 230 Huntersville NC US 28078 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 167173 | 1012864928 | K162430 | UniStrip1 Generic Blood Glucose Test Strips | NBW | 2017-01-19 |
| 167173 | 1862530678 | K160038 | UniStrip1 Generic Blood Glucose Test Strips | NBW | 2016-07-29 |
| 167173 | 1163073684 | K060467 | PRODIGY BLOOD GLUCOSE TEST SYSTEM | NBW | 2006-07-13 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| NBW | 3 | 2017-01-19 |
PMN#
GUDID#
UniStrip1 Generic Blood Glucose Test Strip - UniStrip1 Generic Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchased before October 2012.
2016-09-24
Equate Blood Glucose Test Strips - Equate Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.
2016-09-24
UniStrip Control Solution Low - UniStrip Control Solution Low 4mL
2016-09-23
Equate Blood Glucose Test Strips - Equate Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.
2016-09-24
UniStrip1 Generic Blood Glucose Test Strip - UniStrip1 Generic Blood Glucose Test Strips (50 ct) For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchased before October 2012.
2016-09-24
UniStrip Control Solution Low - UniStrip Control Solution Low 4mL
2016-09-23