COAGUSENSE INC.

Address:48377 Fremont Blvd Ste 113,Fremont,CA,94538,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

Test, Time, Prothrombin (GJS) (10)

Premarket Exempt

Clear

Coag-sense - 00860007370861 Catalog Number : 06F73-03

Device Description : Coag-Sense PT/INR Professional 3-Box Promo

Device Class : 2

Duns Number: 007943352

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

Coag-sense - 00860007370878 Catalog Number : 06F73-05

Device Description : Coag-Sense PT/INR Professional 5-Box Promo

Device Class : 2

Duns Number: 007943352

Premarket Exempt : No

Product Code : GJS

Prescription Use : No

Device Count : 1

Coag-Sense - 00861900000305 Catalog Number : 03P63-01

Device Description : Coag-Sense PT/INR Meter

Device Class : 2

Duns Number: 007943352

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

Coag-sense - 00861900000312 Catalog Number : 03P60-01

Device Description : Coag-Sense PT/INR Professional System

Device Class : 2

Duns Number: 007943352

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

Coag-sense - 00861900000329 Catalog Number : 03P50-01

Device Description : Coag-Sense PT/INR Patient Self-Test System

Device Class : 2

Duns Number: 007943352

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

Coag-sense - 00861900000336 Catalog Number : 03P56-50

Device Description : Coag-Sense Test Strip Kit - 50 Ct

Device Class : 2

Duns Number: 007943352

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

Coag-sense - 00861900000343 Catalog Number : 03P69-10

Device Description : Coag-Sense Professional Control Test Strip Kit - 10 Ct

Device Class : 2

Duns Number: 007943352

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

Coag-Sense PT/INR Meter - 00861900000350 Catalog Number : 03P73-01

Device Description : Coag-Sense PT/INR Meter

Device Class : 2

Duns Number: 007943352

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

Coag-Sense PT/INR Professional System - 00861900000374 Catalog Number : 03P70-02

Device Description : Coag-Sense PT/INR Professional System

Device Class : 2

Duns Number: 007943352

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

Coag-Sense PT/INR Patient Self-Test System - 00861900000381 Catalog Number : 03P70-01

Device Description : Coag-Sense PT/INR Patient Self-Test System

Device Class : 2

Duns Number: 007943352

Premarket Exempt : No

Product Code : GJS

Prescription Use : Yes

Device Count : 1

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