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

Clear

Easy Talk - 04719871820209 Catalog Number :

Device Description : Easy Talk Control Solution-Low(Box)

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : CGA, JJX, NBW

Prescription Use : No

Device Count : 1

Oracle - 04719871820216 Catalog Number :

Device Description : Oracle Blood Glucose Monitoring System

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : Yes

Device Count : 1

Perfect 3 - 04719871820223 Catalog Number :

Device Description : Perfect 3 Meter Only:

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : NBW, CGA, JJX

Prescription Use : No

Device Count : 1

Oracle - 04719871820230 Catalog Number :

Device Description : Oracle Blood Glucose Test Strip(BY8818G0NL4)

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : Yes

Device Count : 1

Perfect 3 - 04719871820247 Catalog Number :

Device Description : Perfect 3 Meter Only

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Oracle - 04719871820254 Catalog Number :

Device Description : Oracle Control Solution- High(BYGOD31BT)

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : Yes

Device Count : 1

Perfect 3 - 04719871820261 Catalog Number :

Device Description : Perfect 3 Blood Glucose Test Strip1.Part Number:BY8818G0NL42.Packing Materials N

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : No

Device Count : 1

Oracle - 04719871820278 Catalog Number :

Device Description : Oracle Control Solution - Medium(BYGOD21BT)

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : NBW, JJX, CGA

Prescription Use : Yes

Device Count : 1

Perfect 3 - 04719871820285 Catalog Number :

Device Description : Perfect 3 Control Solution-High

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : NBW, CGA, JJX

Prescription Use : No

Device Count : 1

Oracle - 04719871820292 Catalog Number :

Device Description : Oracle Control Solution - Low(BYGOD11BT)

Device Class : 1

Duns Number: 658447255

Premarket Exempt : No

Product Code : JJX, CGA, NBW

Prescription Use : Yes

Device Count : 1

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