Alere NMP22 Test

GUDID 10811877010545

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

Alere Scarborough, Inc.

Nuclear matrix protein 22 IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 10811877010545
• NIH Device Record Key: 12c8f072-32e6-49b0-91ab-6b28ac2a6fd2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere NMP22 Test
• Version Model Number: D1100E
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877010545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Approval: P940035

FDA Product Code

• NAH: System, Test, Tumor Marker, For Detection Of Bladder Cancer

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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