Progensa - URINE SPECIMENT TRANSPORT TUBES
Device Description
A collection of reagents and other associated materials 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 using a nucleic acid technique (NAT).
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: 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 IdentifiersDevice Id: 15420045500822
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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