DAB Away Kit

Basic Information

• Brand Name: DAB Away Kit
• Primary DI: 00850042030165
• Version / Model: 1
• Company Name: Lumatas Biosystems, Inc.
• Labeler DUNS: 080169635
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-10-25
• Public Version: 1
• Public Version Date: 2023-11-02
• Public Version Status: New
• Public Device Record Key: c9d03ab3-f80d-4bed-8e11-08ffe15f6077

Device Description

A cleaning kit containing three components. Used for the removal of DAB from Automated Tissue Staining Instrument.

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
59058	Wash/cleaning solution IVD, automated/semi-automated system	A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850042030165	GS1

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 18 – 25 Degrees Celsius