It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System.

It is used for the quantitiative determination of Prostate Specific Antigen(PSA) in human specimen using FREND System.
FREND - FREND PSA Plus

A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total prostate specific antigen (tPSA) in a clinical specimen, using a fluorescent immunoassay method.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: LTJ

Device Name: Prostate-Specific Antigen (Psa) For Management Of Prostate Cancers

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: IM

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: 866.6010

Third Party Flag: Y

Medical Specialty: IM

Device Id: 08809317540481

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