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 - 00054749003716 Catalog Number : 04P75-32

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 - 00054749003723 Catalog Number : 04P75-33

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 - 00054749003730 Catalog Number : 04P75-34

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 - 00054749003747 Catalog Number : 04P75-35

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 - 00054749003754 Catalog Number : 04P75-36

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 - 00054749003761 Catalog Number : 04P75-37

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 - 00054749003778 Catalog Number : 04P75-38

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 - 00054749003785 Catalog Number : 03P75-57

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 - 00054749003792 Catalog Number : 03P75-58

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 - 00054749003808 Catalog Number : 03P75-59

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

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