Immunalysis

Basic Information

• Brand Name: Immunalysis
• Primary DI: 00840937113936
• Version / Model: QS-76501
• Catalog Number: QS-76501
• Company Name: IMMUNALYSIS CORPORATION
• Labeler DUNS: 080589004
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 100
• Record Status: Published
• Publish Date: 2023-03-29
• Public Version: 4
• Public Version Date: 2023-12-18
• Public Version Status: Update
• Public Device Record Key: 7924e01b-57f4-4d72-8980-38a3a403ec43

Device Description

Quantisal Saliva Collection Device - 100 Per Box, Specimen Bag - 100 Per Box

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• 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

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PJD	Oral Fluid Drugs Of Abuse And Alcohol Test Specimen Collection Device	Clinical Chemistry	862.1675	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61164	Oral/upper respiratory tract specimen collection kit	A collection of devices intended exclusively for professional use for the collection, and preservation and/or transport, of a saliva/oral, nasal, nasopharyngeal, and/or oropharyngeal specimen for subsequent laboratory analysis [e.g., nucleic acid technique (NAT), microbiological culture]. The kit consists of a non-suctioning sampling/collection tool(s) [e.g., swab, brush, spatula, saliva collection mouthpiece/funnel] and a covered specimen receptacle with or without an additive/medium [e.g., preservative solution, microbiological medium (e.g., Amies, Stuart, viral transport/inactivation medium)]. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	00840937103142	GS1
Primary	00840937113936	GS1