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) (10)

Premarket Exempt

No Yes

Clear

Alinity - 00380740181000 Catalog Number : 09P533A

Device Description : Alinity c SerBENZQ Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740185787 Catalog Number : 09P261B

Device Description : Alinity i Active B12 Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740185978 Catalog Number : 07P569A

Device Description : Alinity c CardiacCRP Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740186159 Catalog Number : 04T811A

Device Description : Alinity c TPRO2 Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740186265 Catalog Number : 04T961A

Device Description : Alinity c GGT2 Asasy File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740186364 Catalog Number : 04U091A

Device Description : Alinity c Uric2 Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740186388 Catalog Number : 04T861A

Device Description : Alinity c AST2 Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740186395 Catalog Number : 04T863A

Device Description : Alinity c AST2F Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740186401 Catalog Number : 04T841A

Device Description : Alinity c ALT2 Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740186418 Catalog Number : 04T843A

Device Description : Alinity c ALT2F Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

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