DIGIVAL Calibration Check Card Pack

GUDID 10811877010798

A calibration check card verifies that the DIGIVAL is functioning correctly

Alere Scarborough, Inc.

Optical laboratory instrument performance standard calibrator/control IVD, reusable

• Primary Device ID: 10811877010798
• NIH Device Record Key: 6a98695a-1a74-479d-a747-ca6a77a194a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIGIVAL Calibration Check Card Pack
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	10811877010798 [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: 5
• Public Version Date: 2023-09-14
• Device Publish Date: 2019-07-08

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