ABBOTT POINT OF CARE INC.

Address:400 College Road East,Princeton,NJ,08540,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, SODIUM (JGS) (3) Multi-analyte controls, all kinds (assayed) (JJY) (3) Somatic gene mutation detection system (OWD) (3) GLUCOSE OXIDASE, GLUCOSE (CGA) (1)

Premarket Exempt

No Yes

Clear

i-STAT - 00054749003914 Catalog Number : 04P75-45

Device Description : i-STAT 1 Analyzer, Immuno Ready

Device Class : 2

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : CGA

Prescription Use : No

Device Count : 1

i-STAT - 00054749004379 Catalog Number :

Device Description : I-STAT ALINITY INSTRUMENT (MODEL 500)

Device Class : 2

Duns Number: 079226216

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

i-STAT - 00054749004386 Catalog Number :

Device Description : I-STAT ALINITY INSTRUMENT (MODEL 500)

Device Class : 2

Duns Number: 079226216

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

i-STAT - 00054749004393 Catalog Number :

Device Description : I-STAT ALINITY INSTRUMENT (MODEL 500)

Device Class : 2

Duns Number: 079226216

Premarket Exempt : No

Product Code : JGS

Prescription Use : No

Device Count : 1

i-STAT - 00054749004959 Catalog Number :

Device Description : I-STAT TBI Calibration Verification Set

Device Class : 1

Duns Number: 079226216

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

i-STAT - 00054749004966 Catalog Number :

Device Description : I-STAT TBI Control L1

Device Class : 1

Duns Number: 079226216

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

i-STAT - 00054749004973 Catalog Number :

Device Description : I-STAT TBI Control L2

Device Class : 1

Duns Number: 079226216

Premarket Exempt : No

Product Code : JJY

Prescription Use : No

Device Count : 1

i-STAT - 00054749005093 Catalog Number :

Device Description : i-STAT 1 Wireless

Device Class : 3

Duns Number: 079226216

Premarket Exempt : No

Product Code : OWD

Prescription Use : No

Device Count : 1

i-STAT - 00054749005123 Catalog Number :

Device Description : i-Stat 1 Wireless Analyzer

Device Class : 3

Duns Number: 079226216

Premarket Exempt : No

Product Code : OWD

Prescription Use : No

Device Count : 1

i-STAT - 00054749005147 Catalog Number :

Device Description : i-Stat 1 Wireless Analyzer

Device Class : 3

Duns Number: 079226216

Premarket Exempt : No

Product Code : OWD

Prescription Use : No

Device Count : 1

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