PMA P990056S046

Device: ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
Applicant: Roche Diagnostics Corp.
PMA number: P990056
Supplement: S046
Product code: MTF
Decision date: 2026-04-29
Classification: Immunology
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Approval order statement: manufacturing and testing improvements to the Elecsys Streptavidin (SA)-coated microparticles

Current openFDA PMA Record#

Device: ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET
Applicant: Roche Diagnostics Corp.
PMA number: P990056
Supplement: S046
Product code: MTF
Generic name: Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
Decision date: 2026-04-29
Decision code: OK30
Date received: 2026-04-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: manufacturing and testing improvements to the Elecsys Streptavidin (SA)-coated microparticles