MATRITECH NMP22 TEST KIT
FDA premarket approval P940035/S002 · decided 2000-01-18
Approval details
- PMA number
- P940035
- Supplement
- S002
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MATRITECH NMP22 TEST KIT
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 1999-07-23
- Decision date
- 2000-01-18
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- The device is used as an aid 1)in the diagnosis of persons with symptoms or risk factors for transitional cell cancer (TCC) of the bladder (cut-off >= 7.5U/ml) in conjunction with and not in lieu of current standard diagnostic procedures and 2) in the management of patients with transitional cell carcinoma of the bladder, after surgical treatment to identify those patients with occult or rapidly recurring TCC (cut-off >10U/ml).
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