Abbott Diagnostics Technologies AS

Address:Kjelsaasveien 161,OSLO,NO

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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

Single (Specified) Analyte Controls (Assayed And Unassayed) (JJX) (1)

Premarket Exempt

No Yes

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Afinion HbA1c Calibration Verification - 07070060014722 Catalog Number : 1116792

Device Description : HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: HbA1c Calibration Verification for use with the Afinion HbA1c Dx test. Content: Control samples L1, L2 and L3, 1 package insert.

Device Class : 1

Duns Number: 515324122

Premarket Exempt : Yes

Product Code : JJX

Prescription Use : No

Device Count : 1

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