- Physicians Office Resource

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

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