MATRITECH NMP22(TM) TEST KIT
FDA premarket approval P940035/S014 · decided 2017-02-27
Approval details
- PMA number
- P940035
- Supplement
- S014
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MATRITECH NMP22(TM) TEST KIT
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2017-01-30
- Decision date
- 2017-02-27
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- New vendor for the resin contained in the nitrocellulose membrane, and extend expiry of the antigen and purified antibodies used in the test.
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