Alere NMP22 Test

Basic Information

• Brand Name: Alere NMP22 Test
• Primary DI: 10811877010545
• Version / Model: D1100E
• Company Name: Alere Scarborough, Inc.
• Labeler DUNS: 154148498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2014-09-01
• Public Version: 4
• Public Version Date: 2024-02-05
• Public Version Status: Update
• Public Device Record Key: 12c8f072-32e6-49b0-91ab-6b28ac2a6fd2

Device Description

For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA).

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NAH	System, Test, Tumor Marker, For Detection Of Bladder Cancer	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
60571	Nuclear matrix protein 22 IVD, kit, enzyme immunoassay (EIA)	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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811877010545	GS1

Premarket Submissions

Submission Number	Supplement Number
P940035	000