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 - 00380740179977 Catalog Number : 07P691C

Device Description : Alinity i Free T3 Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740179984 Catalog Number : 08P021B

Device Description : Alinity c AlbuminBCG Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740179991 Catalog Number : 07P761B

Device Description : Alinity c Chol Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180003 Catalog Number : 09P861B

Device Description : Alinity c Prealbumin Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180010 Catalog Number : 07P771B

Device Description : Alinity c Trig Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180027 Catalog Number : 07P751B

Device Description : Alinity c Ultra HDL Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180034 Catalog Number : 07P591B

Device Description : Alinity c U/CSF Prot Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180041 Catalog Number : 09P931B

Device Description : Alinity c Cerulo Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180058 Catalog Number : 08P551B

Device Description : Alinity c Gentamicin Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180089 Catalog Number : 08P041B

Device Description : Alinity c Microalb Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

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