Alere NMP22 BladderChek Control Kit

Basic Information

• Brand Name: Alere NMP22 BladderChek Control Kit
• Primary DI: 10811877010606
• Version / Model: D1250
• 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: 3
• Public Version Date: 2023-09-14
• Public Version Status: Update
• Public Device Record Key: e93f983e-80c7-4f4e-91aa-cd1cc13e9a5b
• Distribution End Date: 2024-04-03

Device Description

The Alere NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control for the Alere NMP22 BladderChek Test.

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• 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
MMW	System, Test, Tumor Marker, Monitoring, Bladder	Immunology	866.6010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
60574	Nuclear matrix protein 22 IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nuclear matrix protein 22 in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811877010606	GS1

Premarket Submissions

Submission Number	Supplement Number
K021231	000