AllergiEnd ST-9

Basic Information

• Brand Name: AllergiEnd ST-9
• Primary DI: B6821000121
• Version / Model: 1000-12
• Catalog Number: 1000-12
• Company Name: MEDSCIENCE RESEARCH GROUP, INC.
• Labeler DUNS: 013114656
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 12
• Record Status: Published
• Publish Date: 2018-11-30
• Public Version: 2
• Public Version Date: 2021-11-30
• Public Version Status: Update
• Public Device Record Key: 56522603-959b-4008-9ff9-483730b13b86
• Distribution End Date: 2021-11-30

Device Description

Asymmetric Multiple Skin Testing Device for Percutaneous Skin Testing, 12 applicators individually package and sold as a unit of 12 applicators.

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: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LDH	System, Delivery, Allergen And Vaccine

GMDN Terms

Code	Name	Definition	Implantable	Status
45539	Allergy testing lancet	A sterile device with a sharp triangular cutting edge at the distal end designed to manually breach the epidermis to facilitate the diagnosis of allergic reactions in skin allergy testing performed by an allergist or other healthcare professional. It is held between the fingertips and pressed transiently, but firmly (not jabbed), at right angles through a drop of an allergen extract into the flexor side of the forearm of a suspected allergic individual. The tip penetrates only the most superficial layers of the skin allowing a small volume of the allergen extract to enter the skin and diffuse into the skin layers below. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B6821000121	HIBCC
Unit of Use	B6821000121Q12	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K172062	000

Storage Conditions

• Type: Handling Environment Temperature
• Temperature Range: -40 – 140 Degrees Fahrenheit