|
Device | DIMENSION VISTA TPSA FLEX REAGENT CARTRIDGE |
Generic Name | Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer |
Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE PO BOX 6101 NEWARK, DE 19714-6101 |
PMA Number | P000021 |
Supplement Number | S026 |
Date Received | 08/27/2014 |
Decision Date | 09/25/2014 |
Product Code |
MTF |
Advisory Committee |
Immunology |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADDITION OF AN ALTERNATE AUTOMATED COLUMN (INTERCHIM PURIFLASH® PURIFICATION SYSTEM) PURIFICATION PROCEDURE TO THE EXISTING MANUAL COLUMN CHROMATOGRAPHY PURIFICATION PROCEDURE IN THE EUROPIUM PARTICLE RAW MATERIAL (EPRM) MANUFACTURING PROCESS. |