ABBOTT LABORATORIES

ABBOTT LABORATORIES

Address:1915 Hurd Drive,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

ELECTRODE, ION SPECIFIC, POTASSIUM (CEM) (2) ELECTRODE, ION SPECIFIC, SODIUM (JGS) (2) ELECTRODE, ION-SPECIFIC, CHLORIDE (CGZ) (2) ANALYZER, CHEMISTRY (PHOTOMETRIC, DISCRETE), FOR CLINICAL USE (JJE) (2) ENZYME IMMUNOASSAY, DIGOXIN (KXT) (1) ENZYME IMMUNOASSAY, GENTAMICIN (LCD) (1) ENZYME IMMUNOASSAY, VALPROIC ACID (LEG) (1) IGM, ANTIGEN, ANTISERUM, CONTROL (DFT) (1) LDL & VLDL PRECIPITATION, HDL (LBR) (1) PREALBUMIN, ANTIGEN, ANTISERUM, CONTROL (JZJ) (1) TRANSFERRIN, ANTIGEN, ANTISERUM, CONTROL (DDG) (1) CALIBRATOR, MULTI-ANALYTE MIXTURE (JIX) (1) CALIBRATOR, PRIMARY (JIS) (1) CALIBRATORS, DRUG SPECIFIC (DLJ) (1)

Premarket Exempt

No Yes

Clear

ARCHITECT - 00380740000202 Catalog Number : 01E0121

Device Description : Immunoglobulin M

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : DFT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740000219 Catalog Number : 01E0221

Device Description : Prealbumin

Device Class : 1

Duns Number: 079226220

Premarket Exempt : Yes

Product Code : JZJ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740000226 Catalog Number : 01E0421

Device Description : Transferrin

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : DDG

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740000233 Catalog Number : 01E0602

Device Description : Digoxin Calibrators

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : DLJ

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740000240 Catalog Number : 01E0621

Device Description : Digoxin

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : KXT

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740000301 Catalog Number : 01E1120

Device Description : Gentamicin

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : LCD

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740000332 Catalog Number : 01E1320

Device Description : Valproic Acid

Device Class : 2

Duns Number: 079226220

Premarket Exempt : No

Product Code : LEG

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740000356 Catalog Number : 01E3120

Device Description : Direct LDL

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : JIX, LBR, JIS

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740000363 Catalog Number : 01E4603

Device Description : ICT Serum Calibrator

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : CGZ, JGS, JJE, CEM

Prescription Use : Yes

Device Count : 1

ARCHITECT - 00380740000370 Catalog Number : 01E4702

Device Description : ICT Urine Calibrator

Device Class : 1

Duns Number: 079226220

Premarket Exempt : No

Product Code : CEM, JGS, CGZ, JJE

Prescription Use : Yes

Device Count : 1

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