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 - 00380740180119 Catalog Number : 08P531D

Device Description : Alinity c Lithium Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180126 Catalog Number : 09P631B

Device Description : Alinity c IgM Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180133 Catalog Number : 08P191C

Device Description : Alinity c Magnesium Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180140 Catalog Number : 08P193C

Device Description : Alinity c MagnesiumU Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180157 Catalog Number : 08P591B

Device Description : Alinity c Salicylate Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180164 Catalog Number : 08P541B

Device Description : Alinity c Phenytoin Assay File

Device Class : 1

Duns Number: 315786293

Premarket Exempt : No

Product Code : JJE

Prescription Use : Yes

Device Count : 1

Alinity - 00380740180171 Catalog Number : 08P437B

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 - 00380740180188 Catalog Number : 08P431B

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 - 00380740180195 Catalog Number : 08P435B

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 - 00380740180201 Catalog Number : 08P433B

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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