UNISTRIP TECHNOLOGIES, LLC

Address:7224 Statesville Road, Suite A,Charlotte,NC,28269,US

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Glucose Oxidase, Glucose (CGA) (2) System, Test, Blood Glucose, Over The Counter (NBW) (2) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

Clear

UniStrip1 Generic Blood Glucose Test Strip - 00389167248501 Catalog Number : 024850

Device Description : UniStrip1 Generic Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, UniStrip1 Generic Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart Meters purchased before October 2012.

Device Class :

Duns Number: 043251054

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 50

UniStrip Control Solution Low - 00389167362108 Catalog Number : 036210

Device Description : UniStrip Control Solution Low 4mL

Device Class : 1

Duns Number: 043251054

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Equate Blood Glucose Test Strips - 00681131104869 Catalog Number : 038600

Device Description : Equate Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, Ultra 2, Ul Equate Blood Glucose Test Strips (50 ct)For use with OneTouch Ultra, Ultra 2, UltraMini & UltraSmart meters purchased before April 2016.

Device Class :

Duns Number: 043251054

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 50

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