TYSON BIORESEARCH INC.

Address:5F., No. 16, 18, 20, 22, Kedong 3rd Rd.,Zhunan Township Miaoli,TW

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Filters

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

System, Test, Blood Glucose, Over The Counter (NBW) (10) Glucose Oxidase, Glucose (CGA) (7)

Premarket Exempt

Clear

EZ Smart-608 Blood Glucose Test Strips (50T) - 04719869700667 Catalog Number :

Device Class :

Duns Number: 658026104

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

TysonBio EVOLVE Blood Glucose Monitoring System - 04719869701046 Catalog Number :

Device Class :

Duns Number: 658026104

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

TysonBio EVOLVE Blood Glucose Test Strips (25T) - 04719869701053 Catalog Number :

Device Class :

Duns Number: 658026104

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

TysonBio EVOLVE Blood Glucose Test Strips (50T) - 04719869701060 Catalog Number :

Device Class :

Duns Number: 658026104

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

TysonBio AC200 Blood Glucose Monitoring System - 04719869701473 Catalog Number :

Device Class :

Duns Number: 658026104

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

TysonBio AC200 Blood Glucose Test Strips (50T) - 04719869701497 Catalog Number :

Device Class :

Duns Number: 658026104

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

TysonBio AC200 Blood Glucose Test Strips (25T) - 04719869701503 Catalog Number :

Device Class :

Duns Number: 658026104

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 1

Tyson Bio HT100 Blood Glucose Monitoring System - 04719869701794 Catalog Number :

Device Class : 2

Duns Number: 658026104

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Tyson Bio HT100 Blood Glucose Test Strip , 25T - 04719869701824 Catalog Number :

Device Class :

Duns Number: 658026104

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

Tyson Bio HT100 Blood Glucose Test Strip , 50T - 04719869701831 Catalog Number :

Device Class :

Duns Number: 658026104

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

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