Alere Reader Calibration Check Card

GUDID 10811877011009

A calibration check card verifies that the Alere™ Reader is functioning correctly

Alere Scarborough, Inc.

Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable Optical laboratory instrument performance standard calibrator/control IVD, reusable

• Primary Device ID: 10811877011009
• NIH Device Record Key: cccac40f-10c7-4e44-9ea0-4526311fabaf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Alere Reader Calibration Check Card
• Version Model Number: LFR-003
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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	10811877011009 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K162642

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2021-05-10
• Device Publish Date: 2017-12-28

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
• 00811877011477 - BinaxNOW COVID-19 Antigen Self Test: 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 00811877011507 - BinaxNOW COVID-19 Antigen Self Test: 2023-09-13 A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
• 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