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Assure PT Care Test Strip Kit

FDA UDI

Class II (US FDA UDI)

by CoaguSense Inc.

Identity

Trade Name
Assure PT Care Test Strip Kit FDA UDI
Generic Name
Prothrombin time (PT) IVD, kit, rapid clotting, clinical FDA UDI
Device Name
Arkray Assure PT Care Test Strip, 50 Count FDA UDI
Model / Reference
350218 FDA UDI
Description
Arkray Assure PT Care Test Strip, 50 Count FDA UDI

Identifiers

Catalog Number
350218 FDA UDI
Primary DI / UDI-DI
00850040656039 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

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

Yes

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

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Assure PT Care Test Strip Kit 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
CoaguSense Inc.

Sources (1)

  • FDA UDI 3e0444f5-17f6-4773-979c-a54dc664931b 34 fields · synced May 30, 2026