ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT
FDA premarket approval P940035/S008 · decided 2012-03-21
Approval details
- PMA number
- P940035
- Supplement
- S008
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2010-11-22
- Decision date
- 2012-03-21
- Days to decision
- 485 days
- Decision code
- APPR
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- APPROVAL FOR THE INTENT TO MANUFACTURE THE NMP22 BLADDERCHEK TEST AND NMP22 BLADDERCHEK CONTROL KIT UNDER ALERE SCARBOROUGH, INC. BRAND NAME. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE FOLLOWING TRADE NAME: ALERE NMP22 BLADDERCHEK TEST, WITH THE FOLLOWING INTENDED USE: THE ALERE NMP22 BLADDERCHEK TEST IS AN IN VITRO IMMUNOASSAY INTENDED FOR THE QUALITATIVE DETECTION OF THE NUCLEAR MITOTIC APPARATUS PROTEIN (NUMA), WHICH IS AN ABUNDANT COMPONENT OF THE NUCLEAR MATRIX PROTEINS, IN URINE
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