FDA.reportPublic FDA data

Epredia

Primary DI
00850037343409
Brand
Epredia
Company
NEW ERIE SCIENTIFIC LLC
Model
Microscope Slide Non Adhesion
Catalog number
X2XER204B
Published
2025-03-11
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
00850037343409PrimaryGS10
10850037343406Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037343409008500373434098500373434090850037343409
1085003734340610850037343406

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

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