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 - 00054749003358 Catalog Number : 03P75-50

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 - 00054749003365 Catalog Number : 03P75-51

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 - 00054749003372 Catalog Number : 03P75-52

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 - 00054749003389 Catalog Number : 03P75-53

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 - 00054749003396 Catalog Number : 03P75-54

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 - 00054749003402 Catalog Number : 03P75-55

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 - 00054749003587 Catalog Number : 03P75-06R

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 - 00054749003600 Catalog Number : 04P75-01R

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 - 00054749003693 Catalog Number : 04P75-30

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 - 00054749003709 Catalog Number : 04P75-31

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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