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

IMMUNOASSAY METHOD, TROPONIN SUBUNIT (MMI) (2) ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (2) ACTIVATED WHOLE BLOOD CLOTTING TIME (JBP) (2) TEST,NATRIURETIC PEPTIDE (NBC) (1) ELECTRODE, ION SPECIFIC, SODIUM (JGS) (1) BIOSENSOR, IMMUNOASSAY, CPK OR ISOENZYMES (MYT) (1) TEST, TIME, PROTHROMBIN (GJS) (1)

Premarket Exempt

No Yes

Clear

i-STAT - 10054749000149 Catalog Number : 03P86-25

Device Description : Celite ACT CARTRIDGE

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : JBP

Prescription Use : No

Device Count : 1

i-STAT - 10054749000156 Catalog Number : 03P87-25

Device Description : Kaolin ACT CARTRIDGE

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : JBP

Prescription Use : No

Device Count : 1

i-STAT - 10054749000163 Catalog Number : 03P88-25

Device Description : CG8+ CARTRIDGE

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : CHL

Prescription Use : No

Device Count : 1

i-STAT - 10054749000170 Catalog Number : 03P89-24

Device Description : PT Cartridge

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : GJS

Prescription Use : No

Device Count : 1

i-STAT - 10054749000187 Catalog Number : 03P90-25

Device Description : TROPONIN CARTRIDGE

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : MMI

Prescription Use : No

Device Count : 1

i-STAT - 10054749000200 Catalog Number : 03P92-25

Device Description : CK-MB Cartridge

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : MYT

Prescription Use : No

Device Count : 1

i-STAT - 10054749000217 Catalog Number : 03P93-25

Device Description : BNP Cartridge

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : NBC

Prescription Use : No

Device Count : 1

i-STAT - 10054749001009 Catalog Number : 05p58-25

Device Description : CARTRIDGE, Total B-hCG

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : CHL

Prescription Use : No

Device Count : 1

i-STAT - 10054749001917 Catalog Number : 09P31-25

Device Description : CARTRIDGE, CHEM8+

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : JGS

Prescription Use : No

Device Count : 1

i-STAT - 10054749001986 Catalog Number : 06P23-25

Device Description : CARTRIDGE, cTnI

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : MMI

Prescription Use : No

Device Count : 1

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