Alere NMP22 BladderChek Control Kit

GUDID 10811877010606

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.

Alere Scarborough, Inc.

Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control Nuclear matrix protein 22 IVD, control

• Primary Device ID: 10811877010606
• NIH Device Record Key: e93f983e-80c7-4f4e-91aa-cd1cc13e9a5b
• Commercial Distribution Discontinuation: 2024-04-03
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere NMP22 BladderChek Control Kit
• Version Model Number: D1250
• Company DUNS: 154148498
• Company Name: Alere Scarborough, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877010606 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K021231

FDA Product Code

• MMW: System, Test, Tumor Marker, Monitoring, Bladder

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2023-09-14
• Device Publish Date: 2014-09-01

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• 10811877010606 - Alere NMP22 BladderChek Control Kit: 2023-09-14 The Alere NMP22 BladderChek Control Kit consists of a Negative and a Positive Control solution for use as an external control fo
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