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Coag-sense

FDA UDI

Class II (US FDA UDI)

by CoaguSense Inc.

Identity

Trade Name
Coag-sense FDA UDI
Generic Name
Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
Device Name
Coag-Sense PT/INR Professional System FDA UDI
Model / Reference
100222 FDA UDI
Description
Coag-Sense PT/INR Professional System FDA UDI

Identifiers

Catalog Number
03P60-01 FDA UDI
Primary DI / UDI-DI
00861900000312 FDA UDI
510(k) Number
K050243 FDA UDI
FDA Product Code
GJS FDA UDI
GMDN Term
Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.7750 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Prothrombin time (PT) IVD, kit, rapid clotting, clinical

Coag-sense by CoaguSense Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Prothrombin time (PT) IVD, kit, rapid clotting, clinical.

Cleared under the same submission

K050243 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CoaguSense Inc.

Sources (1)

  • FDA UDI 2c44a7b7-3bb0-481d-84ed-cbce009a24f4 36 fields · synced Jun 6, 2026