ALERE NMP22 BLADDERCHEK TEST
FDA premarket approval P940035/S011 · decided 2015-07-28
Approval details
- PMA number
- P940035
- Supplement
- S011
- 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
- 2015-07-01
- Decision date
- 2015-07-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NAH
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Scarborough, ME
- Statement
- CHANGE IN THE MANUFACTURING PROCESS OF THE ALERE NMP22 BLADDERCHEK TEST, IN WHICH HEAT TREATED NORMAL MOUSE SERUM IS USED INSTEAD OF NORMAL MOUSE SERUM AS A CONTROL TEST LINE BLOCKING AGENT.
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