ABBOTT LABORATORIES

Address:4551 Great America Pkwy,SANTA CLARA,CA,95054,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

Counter, differential cell (GKZ) (4) ENZYME IMMUNOASSAY, VALPROIC ACID (LEG) (2) CALIBRATORS, DRUG SPECIFIC (DLJ) (2) IMMUNOASSAY METHOD, TROPONIN SUBUNIT (MMI) (1) Multi-analyte controls, all kinds (assayed) (JJY) (1) CALIBRATOR, PRIMARY (JIS) (1) SINGLE (SPECIFIED) ANALYTE CONTROLS (ASSAYED AND UNASSAYED) (JJX) (1) CALIBRATOR, SECONDARY (JIT) (1) FLUOROMETRIC METHOD, CPK OR ISOENZYMES (JHX) (1)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740001810 Catalog Number : 01P3501

Device Description : ARCHITECT iValproic Acid Calibrators

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : LEG, DLJ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001827 Catalog Number : 01P3525

Device Description : ARCHITECT iValproic Acid Reagent Kit

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : DLJ, LEG

Prescription Use : Yes

Device Count : 1

CELL-DYN - 00380740002688 Catalog Number : 02H3001

Device Description : CELL-DYN 3700

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

CELL-DYN - 00380740002695 Catalog Number : 02H3003

Device Description : CELL-DYN 3700

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

CELL-DYN - 00380740002725 Catalog Number : 02H3101

Device Description : CELL-DYN 3700

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

CELL-DYN - 00380740002732 Catalog Number : 02H3103

Device Description : CELL-DYN 3700

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : GKZ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003180 Catalog Number : 02K4101

Device Description : ARCHITECT STAT Troponin-I Calibrators

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIT, MMI

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003197 Catalog Number : 02K4110

Device Description : ARCHITECT STAT Troponin-I Controls

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JJX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003227 Catalog Number : 02K4201

Device Description : ARCHITECT STAT CK-MB Calibrators

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIS, JHX

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740003234 Catalog Number : 02K4210

Device Description : ARCHITECT STAT CK-MB Controls

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JJY

Prescription Use : Yes

Device Count : 1

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