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BFT II Analyzer

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
BFT II Analyzer FDA UDI
Generic Name
Coagulation analyser IVD, laboratory, semi-automated FDA UDI
Device Name
The BFT II Analyzer is a semi-automated device intended for use to determine PT, APTT and Fibrinogen FDA UDI
Model / Reference
10458677 FDA UDI
Description
The BFT II Analyzer is a semi-automated device intended for use to determine PT, APTT and Fibrinogen FDA UDI

Identifiers

Catalog Number
OVKF032 FDA UDI
Primary DI / UDI-DI
00842768024887 FDA UDI
510(k) Number
K984501 FDA UDI
FDA Product Code
JPA FDA UDI
GMDN Term
Coagulation analyser IVD, laboratory, semi-automated 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Coagulation analyser IVD, laboratory, semi-automated

BFT II Analyzer by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Coagulation analyser IVD, laboratory, semi-automated.

Cleared under the same submission

K984501 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Siemens Healthcare Diagnostics Products Ltd

Sources (1)

  • FDA UDI c8051e78-a648-4777-931f-523ecaa52151 36 fields · synced May 31, 2026