ABBOTT LABORATORIES

Address:1921 Hurd Dr,IRVING,TX,75038,US

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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) (4)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740202156 Catalog Number : 08G9823

Device Description : ARCHITECT cSystems Assay Disk Conventional Units version 20.0

Device Class : 1

Duns Number: 079226220

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740202163 Catalog Number : 04J6223

Device Description : ARCHITECT cSystems Assay Disk SI Units version 20.0

Device Class : 1

Duns Number: 079226220

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740202231 Catalog Number : 04P5524

Device Description : ARCHITECT System e-Assay CD-ROM-US Version 24.0

Device Class : 1

Duns Number: 079226220

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740202248 Catalog Number : 04P5726

Device Description : ARCHITECT i1000SR System e-Assay CD-ROM-US Version 26.0

Device Class : 1

Duns Number: 079226220

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

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