DIGIVAL Tray Pack 1

Basic Information

• Brand Name: DIGIVAL Tray Pack 1
• Primary DI: 10811877011214
• Version / Model: LFR-004
• Company Name: Alere Scarborough, Inc.
• Labeler DUNS: 154148498
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-07-08
• Public Version: 3
• Public Version Date: 2023-09-12
• Public Version Status: Update
• Public Device Record Key: 05547e76-6d68-49a0-af07-e9299dd74577

Device Description

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).

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
63186	Immunoassay reagent vehicle tray IVD, reusable	A removable tray designed to be loaded with an immunoassay reagent vehicle (e.g., test strip, cassette, card), after vehicle exposure to an in vitro diagnostic clinical specimen, and inserted into an immunoassay analyser. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10811877011214	GS1

Premarket Submissions

Submission Number	Supplement Number
K162642	000