FDA.reportPublic FDA data

Alpha-Tec Systems

Primary DI
00816085020105
Brand
Alpha-Tec Systems
Company
Alpha-TEC Systems, Inc.
Model
0
Catalog number
S003223
Device description
CELL-BOND Slide, 1 Red well, no background
Published
2022-08-11
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
00816085020105PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816085020105008160850201058160850201050816085020105

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
103105524
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816085020549Alpha-Tec Systems000032482022-08-11
00816085020921Alpha-Tec Systems000043022022-08-11
00816085020938Alpha-Tec Systems000043032022-08-11
00816085020945Alpha-Tec Systems000043042022-08-11
00816085020952Alpha-Tec Systems000043052022-08-11
00816085020969Alpha-Tec Systems000043062022-08-11
00816085020976Alpha-Tec Systems000043072022-08-11
00816085020983Alpha-Tec Systems000043082022-08-11
00816085020990Alpha-Tec Systems000043092022-08-11
00816085023069Alpha-Tec Systems000034532022-08-11
00816085023670Alpha-Tec Systems000033712022-08-11
00816085024073Alpha-Tec Systems000048132022-08-11
00816085020075Alpha-Tec Systems0S0032222022-08-11
00816085020273Alpha-Tec Systems02022-08-11
00816085020334Alpha-Tec Systems0S0032242022-08-11
00816085020167Alpha-Tec Systems00003248S2022-08-11
00816085020655Alpha-Tec Systems000033592022-08-11
00816085020877Alpha-Tec Systems0X0000202022-08-11
00816085020884Alpha-Tec Systems0X0034412022-08-11
00816085020891Alpha-Tec Systems0X0034572022-08-11

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