QuikCoag PT-HS

FDA UDI

Class II (US FDA UDI)

by Biomedica Diagnostics Inc

Identity

Trade Name: QuikCoag PT-HS FDA UDI
Generic Name: Prothrombin time (PT) IVD, reagent FDA UDI
Model / Reference: 2 mL FDA UDI

Identifiers

Primary DI / UDI-DI: 00627944000011 FDA UDI
510(k) Number: K020840 FDA UDI
FDA Product Code: GJS FDA UDI
GMDN Term: Prothrombin time (PT) IVD, reagent 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Prothrombin time (PT) IVD, reagent

QuikCoag PT-HS by Biomedica Diagnostics Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K020840 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Biomedica Diagnostics Inc

Sources (1)

FDA UDI f18ff10e-b36a-4f03-b10b-ade4a541701e 34 fields · synced Jun 1, 2026