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

• 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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