Immunalysis Corporation

Basic Information

• Brand Name: Immunalysis Corporation
• Primary DI: 00840937111826
• Version / Model: QSI-0025
• Catalog Number: QSI-0025
• Company Name: IMMUNALYSIS CORPORATION
• Labeler DUNS: 080589004
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-11-26
• Public Version: 5
• Public Version Date: 2023-11-14
• Public Version Status: Update
• Public Device Record Key: 03701a2f-e536-4470-85f5-c9bf6461279e

Device Description

Immunalysis Corporation - Quantisal Saliva Collection Devices - 25 Per Box

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

GMDN Terms

Code	Name	Definition	Implantable	Status
38868	Drug-testing specimen collection kit IVD	A covered receptacle and other associated materials/tools, available for use in the home and clinical settings, intended to be used for the collection, and preservation and/or transport, of a clinical specimen that may include hair, urine, sweat, or saliva suitable for drug testing and/or other in vitro diagnostic investigation. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840937111826	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

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