Alere NMP22 BladderChek Test
FDA premarket approval P940035/S013 · decided 2016-09-08
Approval details
- PMA number
- P940035
- Supplement
- S013
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Alere NMP22 BladderChek Test
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2016-08-16
- Decision date
- 2016-09-08
- Days to decision
- 23 days
- Decision code
- OK30
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- Additional vendor for the goat anti-mouse lgG antibody used in the manufacture of the Alere NMP22® BladderChek® Test procedural control line.
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