Dimension Vista TPSA Flex reagent cartridge
FDA premarket approval P000021/S042 · decided 2021-10-08
Approval details
- PMA number
- P000021
- Supplement
- S042
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Dimension Vista TPSA Flex reagent cartridge
- Generic name
- Total, prostate specific antigen (noncomplexed & complexed) for detection of prostate cancer
- Applicant
- Siemens Healthcare Diagnostics
- Date received
- 2020-06-01
- Decision date
- 2021-10-08
- Days to decision
- 494 days
- Decision code
- APPR
- Product code
- MTF
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Newark, DE
- Statement
- Approval for a change in the manufacturing process of streptavidin.
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