BCS® XP System

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name: BCS® XP System FDA UDI
Generic Name: Coagulation analyser IVD, laboratory FDA UDI
Device Name: The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma FDA UDI
Model / Reference: 10459330 FDA UDI
Description: The Behring Coagulation System (BCS XP System) performs quantitative assays of specific parameters in human citrated plasma FDA UDI

Identifiers

Catalog Number: OVOB03 FDA UDI
Primary DI / UDI-DI: 00630414945514 FDA UDI
510(k) Number: K970431 FDA UDI
FDA Product Code: GKP FDA UDI
GMDN Term: Coagulation analyser IVD, laboratory FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 864.5400 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Coagulation analyser IVD, laboratory

BCS® XP System by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K970431 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: Siemens Healthcare Diagnostics Products Ltd

Sources (1)

FDA UDI d7987d66-3186-4ba8-a1dc-8354cdb37921 36 fields · synced May 30, 2026