Alinity i Free PSA Controls

Alinity i Free PSA Controls
Alinity - 07P9310

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of free (unbound) prostate specific antigen (fPSA) in any of the isoforms [i.e., benign PSA (BPSA), inactive/intact PSA, and/or the PSA precursor, proPSA] in a clinical specimen.

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: MTG

Device Name: Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

Device Class: 3

Physical State: N/A

Definition: N/A

Submission Type ID: 2

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: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 00380740130312

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