FDA.reportPublic FDA data

Multi-Test Dipwell Tray

Primary DI
00892093002067
Brand
Multi-Test Dipwell Tray
Company
Lincoln Diagnostics, Inc.
Model
MHDWC-1
Device description
Antigen tray for use as part of the Multi-Test II and Multi-Test PC system, accessory.
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

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
00892093002067PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00892093002067008920930020678920930020670892093002067

GMDN Terms#

Term, Definition table
TermDefinition
Medicine trayA tray designed to hold supplies and provide a platform for organizing, preparing, and administering medication. It can hold items, e.g., medication cups, syringes, medication cards, alcohol swabs, needle destruction devices and disposal bags. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
054220009
Device count
1

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
00892093002050Duotip-Test II Skin Test SystemLDT II-4002025-12-12
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
00892093002050Duotip-Test II Skin Test SystemLincoln 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