Xprecia™ Systems PT Controls

FDA UDI

Class II (US FDA UDI)

by Universal Biosensors Pty Ltd

Identity

Trade Name: Xprecia™ Systems PT Controls FDA UDI
Generic Name: Prothrombin time (PT) IVD, control FDA UDI
Device Name: Xprecia™ Systems PT Controls is a combination package containing lyophilized normal and abnormal plasma controls to be reconstituted with CaCl2 diluent for use with Xprecia™ Coagulation Systems for PT/INR determinations by professional healthcare providers. FDA UDI
Model / Reference: 90506 FDA UDI
Description: Xprecia™ Systems PT Controls is a combination package containing lyophilized normal and abnormal plasma controls to be reconstituted with CaCl2 diluent for use with Xprecia™ Coagulation Systems for PT/INR determinations by professional healthcare providers. FDA UDI

Identifiers

Catalog Number: 90506 FDA UDI
Primary DI / UDI-DI: 09360136000055 FDA UDI
510(k) Number: K151964 FDA UDI
FDA Product Code: GGN FDA UDI
GMDN Term: Prothrombin time (PT) IVD, control FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5425 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

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, control

Xprecia™ Systems PT Controls by Universal Biosensors Pty Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Prothrombin time (PT) IVD, control.

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Xprecia™ System PT Controls — Siemens Healthcare Diagnostics · Class II
George King Coumadin® Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II
CRYOcheck™ Abnormal 1 Control — Precision Biologic · Class II
QuikCoag Control Level 2 Low Abnormal — Biomedica Diagnostics Inc · Class II
George King Coumadin® Plasma — GEORGE KING BIO-MEDICAL, INC. · Class II

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: Universal Biosensors Pty Ltd

Sources (1)

FDA UDI ea609599-6329-46fd-8e9e-f6a0f016e8dc 37 fields · synced May 30, 2026