BIONIME CORPORATION

Address:NO. 100, Sec. 2, Daqing St., South Dist.,Taichung City,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) (9) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

Clear

GE - 00883489001214 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 25

GE - 00883489001238 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 25

GE - 00883489001252 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 25

GE - 00883489001276 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 25

GE - 00883489001337 Catalog Number :

Device Class : 1

Duns Number: 658637244

Premarket Exempt : No

Product Code : JJX, NBW

Prescription Use : No

Device Count : 1

GE - 00883489001351 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 10

GE - 00883489001375 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 10

GE - 00883489001399 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 10

Rightest - 00883489001405 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 10

Rightest - 00883489001412 Catalog Number :

Device Class :

Duns Number: 658637244

Premarket Exempt : No

Product Code : NBW, CGA

Prescription Use : No

Device Count : 10

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