NMP22 BladderChek Test

GUDID 00811877011538

NMP22 BladderChek Test is an in vitro immunoassay intended for the qualitative detection of the nuclear mitotic apparatus protein (NuMA) in urine of persons with risk factors or symptoms of bladder cancer or with a history of bladder cancer.

Alere Scarborough, Inc.

Nuclear matrix protein 22 IVD, kit, rapid ICT, clinical

• Primary Device ID: 00811877011538
• NIH Device Record Key: 6ef81328-3ed8-495a-9ca3-b87e5955f359
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NMP22 BladderChek Test
• Version Model Number: D1200
• 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	00811877011538 [Primary]

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-08-16
• Device Publish Date: 2022-08-08

Devices Manufactured by Alere Scarborough, Inc.

• 10811877010545 - Alere NMP22 Test: 2023-09-14 For the in vitro quantitative measurement of the Nuclear Matrix Protein NMP22 in stabilized urine (ELISA).
• 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
• 10811877010637 - Alere NMP22® Urine Collection Kit: 2023-09-14 The Alere NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will b
• 10811877010798 - DIGIVAL Calibration Check Card Pack: 2023-09-14 A calibration check card verifies that the DIGIVAL is functioning correctly
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• 00811877011798 - BinaxNOW COVID-19 Antigen Self Test: 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 10811877010019 - Alere i Influenza A & B 2: 2023-09-12 A rapid, automated, molecular test for the qualitative detection of influenza A and B viral nucleic acid in respiratory specimen