Multi-Test Skin Test System

GUDID 00892093002005

Multiple head skin test applicator for allergy testing, box of 6.

Lincoln Diagnostics, Inc.

Allergy testing lancet

• Primary Device ID: 00892093002005
• NIH Device Record Key: 8a087d2f-9bbe-4177-a4c5-9291732d3a5f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Multi-Test Skin Test System
• Version Model Number: MH-6
• Company DUNS: 054220009
• Company Name: Lincoln Diagnostics, Inc.
• Device Count: 6
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00892093002005 [Primary]
GS1	00892093002104 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K760699

FDA Product Code

• SCL: Allergen And Vaccine Delivery Needles

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-12-22
• Device Publish Date: 2025-12-12

On-Brand Devices [Multi-Test Skin Test System]

• 00892093002012: Multiple head skin test applicator for allergy testing with eight testing heads, case of 600.
• 00892093002005: Multiple head skin test applicator for allergy testing, box of 6.