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PFA-100® System

FDA UDI

Class II (US FDA UDI)

by Siemens Healthcare Diagnostics Products Ltd

Identity

Trade Name
PFA-100® System FDA UDI
Generic Name
Platelet aggregation analyser IVD FDA UDI
Device Name
To aid in the detection of platelet dysfunction in citrated human whole blood FDA UDI
Model / Reference
10444868 FDA UDI
Description
To aid in the detection of platelet dysfunction in citrated human whole blood FDA UDI

Identifiers

Catalog Number
B4170-00 FDA UDI
Primary DI / UDI-DI
00842768024870 FDA UDI
510(k) Number
K060489 FDA UDI
FDA Product Code
JOZ FDA UDI
GMDN Term
Platelet aggregation analyser IVD FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
864.5700 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: Platelet aggregation analyser IVD

PFA-100® System by Siemens Healthcare Diagnostics Products Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Platelet aggregation analyser IVD.

Cleared under the same submission

K060489 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 3c0fa666-2147-4759-8077-64372d25ab5a 36 fields · synced Jun 8, 2026