DIGIVAL Tray Pack 1

GUDID 10811877011214

A tray insert to be used with the DIGIVAL to ensure correct placement of the immunoassay reagent vehicle (e.g., test strip, cassette, or card).

Alere Scarborough, Inc.

Immunoassay reagent vehicle tray IVD, reusable

• Primary Device ID: 10811877011214
• NIH Device Record Key: 05547e76-6d68-49a0-af07-e9299dd74577
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DIGIVAL Tray Pack 1
• Version Model Number: LFR-004
• 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	10811877011214 [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: 2
• Public Version Date: 2022-06-10
• Device Publish Date: 2019-07-08

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