FDA.reportPublic FDA data

Epredia

Primary DI
00850037343836
Brand
Epredia
Company
NEW ERIE SCIENTIFIC LLC
Model
Microscope Slide Non Adhesion
Catalog number
X8X30819HRHTC
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
00850037343836PrimaryGS10
10850037343833Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850037343836008500373438368500373438360850037343836
1085003734383310850037343833

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
20810050855833Microscope SlidesTYPENEX MEDICAL LLCKEW2026-03-23
00612479124448McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124455McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479124462McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160651McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160668McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
00612479160675McKessonMCKESSON MEDICAL-SURGICAL INC.KEW2026-03-11
09551020410092PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410320PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410337PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410344PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410351PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
09551020410368PathTezt®BIOCYTECH CORPORATION SDN. BHD.KEW2026-03-11
20194484321585N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
20194484321592N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-11
20194484321530N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321561N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321578N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-09
20194484321264N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321271N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321301N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321318N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321325N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321332N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
20194484321349N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KEW2025-08-08
00849832023210Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024170Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024316Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024323Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23
00849832024354Leica BiosystemsLeica Biosystems Richmond, Inc.KEW2025-07-23