PMA P940035S003
- Device
- NMP22 BLADDERCHEK TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S003
- Product code
- NAH
- Decision date
- 2003-04-25
- Classification
- System, Test, Tumor Marker, For Detection Of Bladder Cancer
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Approval order statement
- APPROVAL FOR NEW TEST FORMAT TO BE MANUFACTURED AT MATRITECH, INC., NEWTON, MASSACHUSETTS AND AT A NEW FACILITY, UNOTECH DIAGNOSTICS, INC., SAN LEANDRO, CALIFORNIA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NMP22 BLADDERCHEK KIT AND IS INDICATED FOR THE FOLLOWING: THE MATRITECH NMP22 BLADDERCHEK TEST IS AN IN VITRO IMMUNOASSAY INTENDED FOR THE QUALITATIVE DETECTION OF NMP22 NUCLEAR MATRIX PROTEIN IN URINE OF PERSONS WITH RISK FACTORS OR SYMPTOMS OF BLADDER CANCER OR WITH A HISTORY OF BLADDER CANCER. THIS TEST IS INDICATED FOR PROFESSIONAL USE AND PRESCRIPTION HOME USE AS AN AID IN DIAGNOSING AND MONITORING BLADDER CANCER PATIENTS, IN CONJUNCTION WITH STANDARD DIAGNOSTIC PROCEDURES.
Current openFDA PMA Record#
- Device
- NMP22 BLADDERCHEK TEST KIT
- Applicant
- Abbott Diagnostics Scarborough, Inc.
- PMA number
- P940035
- Supplement
- S003
- Product code
- NAH
- Generic name
- System, test, tumor marker, for detection of bladder cancer
- Decision date
- 2003-04-25
- Decision code
- APPR
- Date received
- 2002-09-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR NEW TEST FORMAT TO BE MANUFACTURED AT MATRITECH, INC., NEWTON, MASSACHUSETTS AND AT A NEW FACILITY, UNOTECH DIAGNOSTICS, INC., SAN LEANDRO, CALIFORNIA. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME NMP22 BLADDERCHEK KIT AND IS INDICATED FOR THE FOLLOWING: THE MATRITECH NMP22 BLADDERCHEK TEST IS AN IN VITRO IMMUNOASSAY INTENDED FOR THE QUALITATIVE DETECTION OF NMP22 NUCLEAR MATRIX PROTEIN IN URINE OF PERSONS WITH RISK FACTORS OR SYMPTOMS OF BLADDER CANCER OR WITH A HISTORY OF BLADDER CANCER. THIS TEST IS INDICATED FOR PROFESSIONAL USE AND PRESCRIPTION HOME USE AS AN AID IN DIAGNOSING AND MONITORING BLADDER CANCER PATIENTS, IN CONJUNCTION WITH STANDARD DIAGNOSTIC PROCEDURES.