Abbott GmbH

Abbott GmbH

Address:Max-Planck-Ring 2,Wiesbaden Hesse,DE

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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

ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (1) Analyzer, Chemistry (Photometric, Discrete), For Clinical Use (JJE) (1)

Premarket Exempt

No Yes

Clear

Alinity - 00380740200053 Catalog Number : 08P433C

Device Description : Alinity c A1cWB Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740200060 Catalog Number : 09P271B

Device Description : Alinity i Anti-CCP Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : No

Device Count : 1

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