For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA).
Alere NMP22 Test - D1100E
Device Description
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nuclear matrix protein 22 (NMP22) [also known as nuclear mitotic apparatus protein 1] in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically used to aid in the diagnosis of urological conditions (e.g., bladder cancer, prostate cancer).
Environmental Conditions
No Data Available
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: NAH
Device Name: System, Test, Tumor Marker, For Detection Of Bladder Cancer
Device Class: 3
Physical State: N/A
Definition: N/A
Submission Type ID: 2
Review Panel: IM
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: N/A
Third Party Flag: N
Medical Specialty: N/A
Device Identifiers
Device Id: 10811877010545
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
