Duotip-Test II Skin Test System

GUDID 00892093002050

Single device skin test applicator for allergy testing, box of 400.

Lincoln Diagnostics, Inc.

Allergy testing lancet

• Primary Device ID: 00892093002050
• NIH Device Record Key: 35281d75-8fb1-448b-ad6d-d2244b180296
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Duotip-Test II Skin Test System
• Version Model Number: LDT II-400
• Company DUNS: 054220009
• Company Name: Lincoln Diagnostics, Inc.
• Device Count: 400
• 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	00892093002050 [Primary]
GS1	00892093002173 [Unit of Use]

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

Devices Manufactured by Lincoln Diagnostics, Inc.

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• 00892093002043 - Duotip-Test Skin Test System: 2025-12-22 Single skin test applicator for allergy testing, box of 400.
• 00892093002050 - Duotip-Test II Skin Test System: 2025-12-22Single device skin test applicator for allergy testing, box of 400.
• 00892093002050 - Duotip-Test II Skin Test System: 2025-12-22 Single device skin test applicator for allergy testing, box of 400.
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• 00892093002081 - Duotip-Test Dipwell Tray: 2025-12-22 Antigen tray for use with Duotip-Test Skin Test System, accessory.