DIGIVAL

GUDID 00811877010623

DIGIVAL is a small bench top instrument to be used in conjunction with Alere™ rapid tests.

Alere Scarborough, Inc.

Photometric immunoassay analyser IVD

• Primary Device ID: 00811877010623
• NIH Device Record Key: 5ba2b0d8-d8da-4d9b-82c1-473df590f79a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIGIVAL
• Version Model Number: EQ00600X
• 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: false
• Serial Number: true
• 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	00811877010623 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-07-16
• Device Publish Date: 2019-07-08

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