FDA.reportPublic FDA data

Leica Biosystems

Primary DI
00849832017646
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
3800121G
Catalog number
3800121G
Device description
Premier Cover Glass 22 x 50mm - 1.5
Published
2025-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
20849832017640PrimaryGS10
00849832017646Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2084983201764020849832017640
00849832017646008498320176468498320176460849832017646

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
082930884
Device count
1000
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
20849832016032Leica 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