LifeScan Europe GmbH

Address:Gubelstrasse 34,CH Zug,CH

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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) (1) SYSTEM, TEST, BLOOD GLUCOSE, OVER THE COUNTER (NBW) (1) Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

Clear

OneTouch Ultra - 00353885458023 Catalog Number : 010-458

Device Description : One Touch Ultra Control Solution

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : JJX

Prescription Use : No

Device Count : 150

OneTouch Ultra Blue - 00353885994255 Catalog Number : 020-994

Device Description : OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2 OneTouch Ultra Test Strips Blue for blood glucose testing with: OneTouch Ultra 2, OneTouch UltraMini, OneTouch Ultra, OneTouch UltraSmart, OneTouch Ping and OneTouch UltraLink Meters

Device Class :

Duns Number: 480240820

Premarket Exempt : No

Product Code : CGA, NBW

Prescription Use : No

Device Count : 25

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