ABBOTT LABORATORIES

Address:100 ABBOTT PARK RD.,Abbott Park,IL,60064,US

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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

CALIBRATORS, DRUG SPECIFIC (DLJ) (4) CALIBRATOR, SECONDARY (JIT) (2) ENZYME IMMUNOASSAY, DIGOXIN (KXT) (2) ENZYME IMMUNOASSAY, DIPHENYLHYDANTOIN (DIP) (2) ENZYME IMMUNOASSAY, PHENOBARBITAL (DLZ) (2) ENZYME IMMUNOASSAY, TRACROLIMUS (MLM) (2) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (2) FLUORESCENCE POLARIZATION IMMUNOASSAY, DIPHENYLHYDANTOIN (TOTAL) (LGR) (2)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740001377 Catalog Number : 01L7725

Device Description : ARCHITECT Tacrolimus Reagent Kit

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : MLM, JIT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001384 Catalog Number : 01L7755

Device Description : ARCHITECT Tacrolimus Whole Blood Precipitation Reagent

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIT, MLM

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001537 Catalog Number : 01L8601

Device Description : ARCHITECT i1000SR

Device Class : 1

Duns Number: 117245596

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001544 Catalog Number : 01L8640

Device Description : ARCHITECT i1000SR INTEGRATED MODULE

Device Class : 1

Duns Number: 117245596

Premarket Exempt : Yes

Product Code : JJE

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001759 Catalog Number : 01P3201

Device Description : ARCHITECT iDigoxin Calibrators

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : KXT, DLJ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001766 Catalog Number : 01P3225

Device Description : ARCHITECT iDigoxin Reagent Kit

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : KXT, DLJ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001773 Catalog Number : 01P3301

Device Description : ARCHITECT iPhenobarbital Calibrators

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : DLJ, DLZ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001780 Catalog Number : 01P3325

Device Description : ARCHITECT iPhenobarbital Reagent Kit

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : DLJ, DLZ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001797 Catalog Number : 01P3401

Device Description : ARCHITECT iPhenytoin Calibrators

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : DIP, LGR

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740001803 Catalog Number : 01P3425

Device Description : ARCHITECT iPhenytoin Reagent Kit

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : DIP, LGR

Prescription Use : Yes

Device Count : 1

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