FDA.reportPublic FDA data

Leica Biosystems

Primary DI
20849832016032
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
3800115ACS
Catalog number
3800115ACS
Device description
Premier Cover Glass 22 x 40mm - 1.0
Published
2025-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KESCoverslips, Microscope Slide

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KESCoverslips, Microscope SlidePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20849832016032PrimaryGS10
00849832016038Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084983201603220849832016032
00849832016038008498320160388498320160380849832016038

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00

Contacts#

Phone, Email table
PhoneEmail
+1(800)5374669tech.support@Leicabiosystems.com
+1(866)4783999tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
840
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10849832027819Leica Biosystems380320038032002026-05-22
20849832027915Leica Biosystems39LP-200-239LP-200-22026-05-13
20849832027946Leica Biosystems39LP-200-539LP-200-52026-05-13
20849832027908Leica Biosystems39LP-200-139LP-200-12026-05-12
20849832027922Leica Biosystems39LP-200-339LP-200-32026-05-12
20849832027939Leica Biosystems39LP-200-439LP-200-42026-05-12
20849832027953Leica Biosystems39LP-200-639LP-200-62026-05-12
20849832027960Leica Biosystems39LP-200-739LP-200-72026-05-12
20849832027977Leica Biosystems39LP-300-039LP-300-02026-05-12
20849832027984Leica Biosystems39LP-300-139LP-300-12026-05-12
20849832027991Leica Biosystems39LP-300-239LP-300-22026-05-12
20849832028004Leica Biosystems39LP-300-339LP-300-32026-05-12
20849832028011Leica Biosystems39LP-300-439LP-300-42026-05-12
20849832028028Leica Biosystems39LP-300-539LP-300-52026-05-12
20849832028035Leica Biosystems39LP-300-639LP-300-62026-05-12
20849832028042Leica Biosystems39LP-300-739LP-300-72026-05-12
20849832028059Leica Biosystems39LP-400-039LP-400-02026-05-12
20849832028066Leica Biosystems39LP-400-139LP-400-12026-05-12
20849832028073Leica Biosystems39LP-400-239LP-400-22026-05-12
20849832028080Leica Biosystems39LP-400-339LP-400-32026-05-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00612479135475McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479135505McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479160415McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
00612479160422McKessonMCKESSON MEDICAL-SURGICAL INC.KES2026-03-11
10194484321557N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-09
10194484321281N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-08
10194484321298N/A (Approved Vendor)GRAINGER INTERNATIONAL, INC.KES2025-08-08
20849832016001Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016018Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016025Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832016049Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017640Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017701Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017756Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017763Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832017794Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832022705Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832022736Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832023207Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832023351Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832023368Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
20849832025645Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-07-20
00810041333988Epredia NEW ERIE SCIENTIFIC LLCKES2025-06-26
10849832013454Leica BiosystemsLeica Biosystems Richmond, Inc.KES2025-06-04
00810041333308Epredia NEW ERIE SCIENTIFIC LLCKES2025-03-17
04064279008088Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26
04064279008262Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26
04064279008637Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26
04064279008682Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26
04064279008927Marienfeld SuperiorPaul Marienfeld GmbH & Co. KGKES2024-04-26