PMA P100033S002
- Device
- PROGENSA PCA3 ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100033
- Supplement
- S002
- Product code
- OYM
- Decision date
- 2015-01-21
- Classification
- Prostrate Cancer Genes Nucleic Acid Amplification Test System
- Generic name
- Prostrate cancer genes nucleic acid amplification test system
- Approval order statement
- MANUFACTURING SCALE UP OF THE SELECTION REAGENT USED IN THE PROGENSA PCA3 ASSAY.
Current openFDA PMA Record#
- Device
- PROGENSA PCA3 ASSAY
- Applicant
- Gen-Probe Incorporated
- PMA number
- P100033
- Supplement
- S002
- Product code
- OYM
- Generic name
- Prostrate cancer genes nucleic acid amplification test system
- Decision date
- 2015-01-21
- Decision code
- OK30
- Date received
- 2014-12-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- MANUFACTURING SCALE UP OF THE SELECTION REAGENT USED IN THE PROGENSA PCA3 ASSAY.