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 - 00380740193638 Catalog Number : 04Z211A

Device Description : Alinity i STAT High Sensitivity Tropopnin-I

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740194093 Catalog Number : 06S611A

Device Description : Alinity i COV 2IgGII Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740194192 Catalog Number : 09P521B

Device Description : Alinity c BenzQ Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740194208 Catalog Number : 09P523B

Device Description : Alinity c BenzSQ Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740195380 Catalog Number : 08P181B

Device Description : Alinity c A-ALT Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740195458 Catalog Number : 07P701C

Device Description : Alinity i Free T4 Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740199487 Catalog Number : 04V511B

Device Description : Alinity c Total Bilirubin Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740200022 Catalog Number : 08P437C

Device Description : Alinity c %A1cH Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740200039 Catalog Number : 08P431C

Device Description : Alinity c A1cH Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740200046 Catalog Number : 08P435C

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

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