NMP22 BladderChek Test
FDA premarket approval P940035 · decided 1996-07-02
Approval details
- PMA number
- P940035
- Trade name
- NMP22 BladderChek Test
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 1994-11-07
- Decision date
- 1996-07-02
- Days to decision
- 603 days
- Decision code
- APPR
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- APPROVAL FOR THE MATRITECH NMP22 TEST KIT. THE MATRITECH NMP22 TEST KIT IS AN ENZYME IMMUNOASSAY (EIA) FOR THE IN VITRO QUANTITATIVE DETERMINATION OF NUCLEAR MATRIX PROTEIN NMP22 IN STABILIZED VOIDED URINE.
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