FDA.reportPublic FDA data

Microscope Slides

Primary DI
10810050855720
Brand
Microscope Slides
Company
TYPENEX MEDICAL LLC
Model
LC0103
Device description
Liquid Based Cytology Slides, Uncoated, Single Printed Circle on Back, Ground Edge 90° Corners
Published
2025-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
KEWSlides, Microscope

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEWSlides, MicroscopePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20810050855727PackageGS120In Commercial Distribution
10810050855720PrimaryGS10
00810050855723Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081005085572720810050855727
1081005085572010810050855720
00810050855723008100508557238100508557230810050855723

GMDN Terms#

Term, Definition table
TermDefinition
General specimen microscopy slide IVD, single-useA glass or plastic microscopy slide intended to be used for the collection, and preservation and/or transport, of any type of clinical specimen or smear for analysis and/or other investigation. This is a single-use device.

Regulatory Flags#

DUNS number
600850213
Device count
72
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810050851954Typenex Introducer SetMS17122020-06-09
00810050853460Typenex Introducer SetMS1235S2021-01-26
00810050853491Typenex Introducer SetMS1335S2021-01-26
00810050853514Typenex Introducer SetMS1835S2021-01-26
00810050853774Typenex Introducer SetMS19122021-08-11
00810050853804Typenex Introducer SetMS21122021-08-11
00810050853811Typenex Introducer SetMS20122021-08-11
00810050853842Typenex Introducer SetMS22122021-08-11
00810050855808Typenex Introducer SetMS2335S2025-11-17
00812269032957Typenex Introducer SetMS02362019-09-18
00812269032971Typenex Introducer SetMS03362019-09-18
00812269032995Typenex Introducer SetMS04362019-09-18
00812269033015Typenex Introducer SetMS05362019-09-18
00812269033039Typenex Introducer SetMS06362019-09-18
00812269033053Typenex Introducer SetMS02442019-09-18
00812269033077Typenex Introducer SetMS03442019-09-18
00812269033091Typenex Introducer SetMS04442019-09-18
00812269033114Typenex Introducer SetMS1144S2019-09-18
00812269033138Typenex Introducer SetMS1244S2019-09-18
00812269033152Typenex Introducer SetMS1344S2019-09-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20849832016322Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2026-10-28
20849832016339Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2026-10-28
20849832016452Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2026-10-28
20849832023139Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2026-10-28
20849832023405Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2026-10-28
20849832023412Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2026-10-28
04262400021054Bio-Gram Microscope SlidesBio-Gram Diagnostics GmbHKEW2026-10-20
04062418017151KT ™ Premium SlidesSlmp, LLCKEW2026-09-21
04062418017175KT ™ Premium SlidesSlmp, LLCKEW2026-09-21
10810050855850Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855867Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855874Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855881Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855898Microscope SlidesTYPENEX MEDICAL LLCKEW2026-05-14
10810050855836Microscope SlidesTYPENEX MEDICAL LLCKEW2026-03-23
00612479124417McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124424McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124431McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160385McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160392McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160408McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
10194484321588N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
10194484321595N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
10194484321533N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321564N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321571N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
10194484321267N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321274N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321304N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321311N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08