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

Somatic gene mutation detection system (OWD) (2) ACID, LACTIC, ENZYMATIC METHOD (KHP) (1) Brain trauma assessment test (QAT) (1) ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH (CHL) (1)

Premarket Exempt

No Yes

Clear

i-STAT - 10054749002266 Catalog Number : 03P85-50

Device Description : CARTRIDGE, CG4+

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : KHP

Prescription Use : No

Device Count : 1

i-STAT - 10054749002280 Catalog Number : 03P78-50

Device Description : CARTRIDGE, G3+

Device Class :

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : CHL

Prescription Use : No

Device Count : 1

i-STAT - 10054749005069 Catalog Number :

Device Description : I-STAT TBI PLASMA CARTRIDGE

Device Class : 2

Duns Number: 079226216

Premarket Exempt : No

Product Code : QAT

Prescription Use : No

Device Count : 1

i-STAT - 10054749005502 Catalog Number :

Device Description : Cartridge, CG4+

Device Class : 3

Duns Number: 079226216

Premarket Exempt : No

Product Code : OWD

Prescription Use : No

Device Count : 1

i-STAT - 10054749005519 Catalog Number :

Device Description : Cartridge, Chem8+

Device Class : 3

Duns Number: 079226216

Premarket Exempt : No

Product Code : OWD

Prescription Use : No

Device Count : 1

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