Progensa

Progensa - PSA CALIBRATORS AND CONTROLS

A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of mRNA expression of the prostate cancer gene 3 (PCA3) and the gene coding for the prostate specific antigen associated with prostate cancer, in a clinical specimen.

No Data Available

No Data Available

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Code: OYM

Device Name: Prostrate Cancer Genes Nucleic Acid Amplification Test System

Device Class: 3

Physical State: Capture oligonucleotides, magnetic microparticles, transcription-based nucleic acid amplification reagents, chemiluminescent-labeled nucleic acid probes. luminometer, software

Definition: An in vitro nucleic acid amplification test that measures the concentration of prostate cancer genes.

Submission Type ID: 2

Review Panel: IM

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: Utilizes nucleic acid probes and/or primers along with other reagents to detect prostrate cancer genes RNA from human specimens.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: Currently this type of device is only utilized on urine specimens, but other specimen types may be possible.

Regulation Number: N/A

Third Party Flag: N

Medical Specialty: N/A

Device Id: 15420045500808

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