ALERE NMP22 URINE COLLECTION KIT
FDA premarket approval P940035/S007 · decided 2012-01-20
Approval details
- PMA number
- P940035
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ALERE NMP22 URINE COLLECTION KIT
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2011-07-27
- Decision date
- 2012-01-20
- Days to decision
- 177 days
- Decision code
- APPR
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- APPROVAL FOR THE NMP22 TEST KIT AND NMP22 URINE COLLECTION KIT UNDER ALERE SCARBOROUGH, INCS BRAND NAME. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER: TRADE NAME ALERE NMP22 TEST WITH THE FOLLOWING INTENDED USE: ALERE NMP22 TEST IS AN ENZYME IMMUNOASSAY (EIA) FOR THE IN VITRO QUANTITATIVE DETERMINATION OF THE NUCLEAR MITOTIC APPARATUS PROTEIN (NUMA) IN STABILIZED VOIDED URINE. THE ALERE NMP22 TEST KIT IS INDICATED AS AN AID 1) IN THE DIAGNOSIS OF PERSONS WITH SYMPTOMS OR RISK FACTORS FOR TRA
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