FDA.reportPublic FDA data

Epredia

Primary DI
00810041335579
Brand
Epredia
Company
NEW ERIE SCIENTIFIC LLC
Model
Microscope Slide Non Adhesion
Catalog number
AG00008232E04MNZ51
Published
2025-03-04
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
00810041335579PrimaryGS10
10810041335576Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041335579008100413355798100413355790810041335579
1081004133557610810041335576

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
361605223
Device count
72
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850040101652Epredia LS-4041I-8524-1CESlideMate Laser Microscope Slides White tab2025-10-22
00850040101669Epredia LS-5041I-8524-1CESlideMate Laser Microscope Slides Blue tab2025-10-22
00850040101676Epredia LS-6041I-8524-1CESlideMate Laser Microscope Slides Green tab2025-10-22
00850040101683EprediaLS-7041I-8524-1CESlideMate Laser Microscope Slides Pink tab2025-10-22
00850040101690EprediaLS-8041I-8524-1CESlideMate Laser Microscope Slides Yellow tab2025-10-22
00850040101706Epredia LS-4041IPS8523-1CESlideMate Laser Plus Microscope Slides White tab2025-10-22
00850040101713Epredia LS-5041IPS8523-1CESlideMate Laser Plus Microscope Slides Blue tab2025-10-22
00850040101720Epredia LS-6041IPS8523-1CESlideMate Laser Plus Microscope Slides Green tab2025-10-22
00850040101737Epredia LS-7041IPS8523-1CESlideMate Laser Plus Microscope Slides Pink tab2025-10-22
00850040101744Epredia LS-8041IPS8523-1CESlideMate Laser Plus Microscope Slides Yellow tab2025-10-22
00850040101751Epredia LS-4041I-4-8560CSlideMate Laser Slides (Non-Adhesion), White Tab 22025-10-22
00850040101768Epredia LS-5041I-4-8560CSlideMate Laser Slides (Non-Adhesion), Blue Tab 252025-10-22
00850040101775Epredia LS-6041I-4-8560CSlideMate Laser Slides (Non-Adhesion), Green Tab 22025-10-22
00850040101782Epredia LS-7041I-4-8560CSlideMate Laser Slides (Non-Adhesion), Pink Tab 252025-10-22
00850040101799Epredia LS-8041I-4-8560CSlideMate Laser Slides (Non-Adhesion), Yellow Tab 2025-10-22
00810041333988Epredia Cover SlipsBB02400500P113MNZ12025-06-26
10810041333985Epredia Cover SlipsBB02400500P113MNZ12025-06-26
00810041333308Epredia BC05000760A140MNZ02025-03-17
00810041333032Epredia Cover SlipsBC06601000A140MNZ12025-03-17
00810041333049Epredia Cover SlipsBC02200250A133AUT02025-03-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10194484321328N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321335N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
10194484321342N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20849832023214Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024174Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024310Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024327Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832024358Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
20849832025331Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23