BIOTEST MEDICAL CORPORATION

BIOTEST MEDICAL CORPORATION

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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

Glucose Oxidase, Glucose (CGA) (10) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (10) System, Test, Blood Glucose, Over The Counter (NBW) (10)

Premarket Exempt

No

Clear

Smartest PersonaII - 04719871820001 Catalog Number :

Device Description : Smartest PersonaII Blood Glucose Monitoring System

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Smartest PersonaII - 04719871820018 Catalog Number :

Device Description : Smartest Persona II Glucose Strip-25pcs

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Smartest PersonaII - 04719871820025 Catalog Number :

Device Description : Smartest PersonaII Control Solution-M

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Smartest PersonaII - 04719871820032 Catalog Number :

Device Description : Smartest PersonaII Glucose Meter

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

B T M - 04719871820049 Catalog Number :

Device Description : Lancing Device

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Easy Plus II - 04719871820056 Catalog Number :

Device Description : Easy Plus II Blood Glucose Monitoring System 6276-S

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Easy Plus II - 04719871820063 Catalog Number :

Device Description : Easy Plus II Glucose Meter, 6276-S

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Easy Plus II - 04719871820070 Catalog Number :

Device Description : Easy Plus II Blood Glucose Test Strip

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Easy Plus II - 04719871820087 Catalog Number :

Device Description : Easy Plus II Control Solution-High

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Easy Plus II - 04719871820094 Catalog Number :

Device Description : Easy Plus II Control Solution-Low

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

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