FDA.reportPublic FDA data

Multi-Test II Skin Test System

Primary DI
00892093002029
Brand
Multi-Test II Skin Test System
Company
Lincoln Diagnostics, Inc.
Model
MH-II 6
Device description
Multiple skin test applicator for allergy testing, box of 6.
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K961918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K961918000MULTI-TEST IILincoln Diagnostics, Inc.1996-08-07SCL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00892093002029PrimaryGS10
00892093002142Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00892093002029008920930020298920930020290892093002029
00892093002142008920930021428920930021420892093002142

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.

Regulatory Flags#

DUNS number
054220009
Device count
6

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00892093002050Duotip-Test II Skin Test SystemLDT II-4002025-12-12
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
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
00892093002050Duotip-Test II 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