PMA P940035S012
- Device
- ALERE NMP22(TM) TEST
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S012
- Product code
- NAH
- Decision date
- 2016-05-06
- Classification
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Approval order 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.
Current openFDA PMA Record#
- Device
- ALERE NMP22(TM) TEST
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S012
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2016-05-06
- Decision code
- OK30
- Date received
- 2016-04-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order 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.