PMA P940035S013
- Device
- Alere NMP22 BladderChek Test
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S013
- Product code
- NAH
- Decision date
- 2016-09-08
- Classification
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Approval order statement
- Additional vendor for the goat anti-mouse lgG antibody used in the manufacture of the Alere NMP22® BladderChek® Test procedural control line.
Current openFDA PMA Record#
- Device
- Alere NMP22 BladderChek Test
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S013
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2016-09-08
- Decision code
- OK30
- Date received
- 2016-08-16
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional vendor for the goat anti-mouse lgG antibody used in the manufacture of the Alere NMP22® BladderChek® Test procedural control line.