Able Diagnostics Inc

Address:12396 World Trade Drive, Suite 216, San Diego, CA 92128,,San Diego,CA,92128,US

Want to know more about this Organization? Request more information now!

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

Lancet, Blood (FMK) (4) System, Test, Blood Glucose, Over The Counter (NBW) (3) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (2) Glucose Oxidase, Glucose (CGA) (1)

Premarket Exempt

No Yes

Clear

VivaGuard Ino - 00853483008007 Catalog Number : VGM01-371

Device Description : VivaGuard Ino Blood Glucose Monitoring System

Device Class : 2

Duns Number: 080952036

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

VivaGuard Ino - 00853483008014 Catalog Number : VGS01-371

Device Description : VivaGuard Ino Test strips 50s (25s/vial)

Device Class : 2

Duns Number: 080952036

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 1

VivaGuard - 00853483008021 Catalog Number : VGL01-382

Device Description : VivaGuard Lancets 50s (30G)

Device Class : 2

Duns Number: 080952036

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

VivaGuard - 00853483008038 Catalog Number : VGD01-381

Device Description : VivaGuard Lancing Device

Device Class : 2

Duns Number: 080952036

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

VivaGuard Ino - 00853483008052 Catalog Number : VGM01-373

Device Description : VivaGuard Ino Blood Glucose Meter Only Kit

Device Class : 2

Duns Number: 080952036

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

VivaGuard Ino - 00853483008076 Catalog Number : VGC01-371

Device Description : VivaGuard Ino Control Solution (L, M, H, 1 bottle/each)

Device Class : 1

Duns Number: 080952036

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

VivaGuard - 00853483008137 Catalog Number : VGL02-382

Device Description : VivaGuard Safety Lancets (100s)

Device Class : 2

Duns Number: 080952036

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

VivaGuard - 00853483008144 Catalog Number : VGL01-383

Device Description : VivaGuard Lancets 100s (30G)

Device Class : 2

Duns Number: 080952036

Premarket Exempt : Yes

Product Code : FMK

Prescription Use : No

Device Count : 1

VivaGuard Ino - 00853483008151 Catalog Number :

Device Description : VivaGuard Ino Blood Glucose Meter

Device Class : 2

Duns Number: 080952036

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

VivaGuard Ino - 00853483008175 Catalog Number : VGC01-373

Device Description : VivaGuard Ino Control Solution 2 (1 bottle/kit)

Device Class : 1

Duns Number: 080952036

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

Previous 1 2 Next