Able Diagnostics Inc

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

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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) (2) Glucose Oxidase, Glucose (CGA) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

VivaGuard Ino - 00853483008182 Catalog Number : VGS01-378

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

Device Class : 2

Duns Number: 080952036

Premarket Exempt : No

Product Code : CGA

Prescription Use : No

Device Count : 1

VivaGuard Ino - 00853483008199 Catalog Number : VGC01-372

Device Description : VivaGuard Ino Control Solution (1 & 3)

Device Class : 1

Duns Number: 080952036

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 1

VivaGuard Ino Smart - 00853483008236 Catalog Number : VGM04-665

Device Description : VivaGuard Ino Smart 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 Smart - 00853483008243 Catalog Number :

Device Description : VivaGuard Ino Smart Blood Glucose Meter

Device Class : 2

Duns Number: 080952036

Premarket Exempt : No

Product Code : NBW

Prescription Use : No

Device Count : 1

VivaGuard® HA-650 Non-Contact Infrared Forehead Thermometer - 00853483008250 Catalog Number : HA-650

Device Description : Accurate and Quick:(1) Advanced infrared technology with a unique Chromed Arched Accurate and Quick:(1) Advanced infrared technology with a unique Chromed Arched Reflector provides highly accurate and quick measurements in 1 second; (2) Features wide body temperature measuring range between 93.2°F – 109.4°F; (3) Offers reliable results in a wide environmental temperature range at 50.0°F – 104.0°F; No Touch and Safer Measurements: (1) Hold the Non-contact thermometer 0.4 – 2 inches away from the center of forehead to obtain measurement; (2) No measuring sensor cover is needed; (3) Minimizes the risk of spread of disease and cross-contamination; (4) Eliminates the need for cleaning between each person; Easy to Use: (1) Easy to read digital LCD display includes 3 backlight colors and features Red High Fever Alert above 101.3°F; (2) User-friendly design offers comfortable grip; (3) Storage for up to 50 measurement memories; (4) Switchable between °F/°C and beep/silent options;(5) 2 AAA batteries included.

Device Class : 2

Duns Number: 080952036

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

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