ALERE NMP22(TM) TEST
FDA premarket approval P940035/S012 · decided 2016-05-06
Approval details
- PMA number
- P940035
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ALERE NMP22(TM) TEST
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- Date received
- 2016-04-06
- Decision date
- 2016-05-06
- Days to decision
- 30 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 Test, in which the manufacture of the antigens used in the manufacture of the urine calibrators and urine controls has been outsourced to a Third Party Vendor.
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