FDA.reportPublic FDA data

Duotip-Test II Skin Test System

Primary DI
00892093002050
Brand
Duotip-Test II Skin Test System
Company
Lincoln Diagnostics, Inc.
Model
LDT II-400
Device description
Single device skin test applicator for allergy testing, box of 400.
Published
2025-12-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
SCLAllergen And Vaccine Delivery Needles

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
SCLAllergen And Vaccine Delivery NeedlesGeneral Hospital2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00892093002050PrimaryGS10
00892093002173Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00892093002050008920930020508920930020500892093002050
00892093002173008920930021738920930021730892093002173

GMDN Terms#

Term, Definition table
TermDefinition
Allergy testing lancetA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054220009
Device count
400

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00892093002029Multi-Test II Skin Test SystemMH-II 62025-12-12
00892093002036Multi-Test II Skin Test SystemMH-II BLK2025-12-12
00892093002005Multi-Test Skin Test SystemMH-62025-12-12
00892093002012Multi-Test Skin Test SystemMH-6 BLK2025-12-12
00892093002142Multi-Test II Skin Test SystemMH-II BLK2025-12-12
00892093002043Duotip-Test Skin Test SystemLDT-1002025-12-12
00892093002067Multi-Test Dipwell TrayMHDWC-12025-12-12
00892093002074Multi-Test Dipwell Tray, non-cappedMHDW-12025-12-12
00892093002081Duotip-Test Dipwell TrayDWT-12025-12-12
00892093002098Wells for Pyramid Dipwell TrayDTW-402025-12-12
00892093002111Multi-Test PC Skin Test SystemMH-6 PC2025-12-12
00892093002128UniTest PC Skin Test SystemUT-4002025-12-12
00892093002135Multi-Test PC Skin Test SystemMH-BLK PC2025-12-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00892093002029Multi-Test II Skin Test SystemLincoln Diagnostics, Inc.SCL2025-12-12
00892093002036Multi-Test II Skin Test SystemLincoln Diagnostics, Inc.SCL2025-12-12
00892093002005Multi-Test Skin Test SystemLincoln Diagnostics, Inc.SCL2025-12-12
00892093002012Multi-Test Skin Test SystemLincoln Diagnostics, Inc.SCL2025-12-12
00892093002142Multi-Test II Skin Test SystemLincoln Diagnostics, Inc.SCL2025-12-12
00892093002043Duotip-Test Skin Test SystemLincoln Diagnostics, Inc.SCL2025-12-12
00892093002067Multi-Test Dipwell TrayLincoln Diagnostics, Inc.SCL2025-12-12
00892093002074Multi-Test Dipwell Tray, non-cappedLincoln Diagnostics, Inc.SCL2025-12-12
00892093002081Duotip-Test Dipwell TrayLincoln Diagnostics, Inc.SCL2025-12-12
00892093002098Wells for Pyramid Dipwell TrayLincoln Diagnostics, Inc.SCL2025-12-12
00892093002111Multi-Test PC Skin Test SystemLincoln Diagnostics, Inc.SCL2025-12-12
00892093002128UniTest PC Skin Test SystemLincoln Diagnostics, Inc.SCL2025-12-12
00892093002135Multi-Test PC Skin Test SystemLincoln Diagnostics, Inc.SCL2025-12-12