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

GLUCOSE OXIDASE, GLUCOSE (CGA) (10)

Premarket Exempt

No Yes

Clear

i-STAT - 00054749003815 Catalog Number : 03P75-60

Device Description : i-Stat 1 Wireless Analyzer

Device Class : 2

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : CGA

Prescription Use : No

Device Count : 1

i-STAT - 00054749003822 Catalog Number : 03P75-61

Device Description : i-Stat 1 Wireless Analyzer

Device Class : 2

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : CGA

Prescription Use : No

Device Count : 1

i-STAT - 00054749003839 Catalog Number : 03P75-62

Device Description : i-Stat 1 Wireless Analyzer

Device Class : 2

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : CGA

Prescription Use : No

Device Count : 1

i-STAT - 00054749003846 Catalog Number : 03P75-63

Device Description : i-Stat 1 Wireless Analyzer

Device Class : 2

Duns Number: 079226216

Premarket Exempt : Yes

Product Code : CGA

Prescription Use : No

Device Count : 1

i-STAT - 00054749003853 Catalog Number : 04P75-39

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 - 00054749003860 Catalog Number : 04P75-40

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 - 00054749003877 Catalog Number : 04P75-41

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 - 00054749003884 Catalog Number : 04P75-42

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 - 00054749003891 Catalog Number : 04P75-43

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 - 00054749003907 Catalog Number : 04P75-44

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

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