- Physicians Office Resource

To aid in the detection of platelet dysfunction in citrated human whole blood
PFA-100® System - 10444868

Device Description

An electrically-powered automated or semi-automated laboratory instrument intended to be used for the qualitative and/or quantitative in vitro examination of platelet function in a clinical specimen, by inducing platelet aggregation through the addition of platelet aggregating agents. The instrument may incorporate various technologies including electrical impedance, photometry, turbidimetry and/or luminescence together with sample processing, data processing and/or data display software.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: JOZ

Device Name: System, Automated Platelet Aggregation

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: HE

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 864.5700

Third Party Flag: Y

Medical Specialty: HE

Device Identifiers

Device Id: 00842768024870

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

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