FDA.reportPublic FDA data

Leica Biosystems

Primary DI
00849832012214
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
14020108926
Catalog number
14020108926
Device description
Tissue freezing medium, 125 ml
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
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KEQMedia, Mounting, Water Soluble

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEQMedia, Mounting, Water SolublePathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849832012211PrimaryGS10
00849832012214Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084983201221110849832012211
00849832012214008498320122148498320122140849832012214

GMDN Terms#

Term, Definition table
TermDefinition
Biological stain IVDA single chemical agent, dye or solution intended for the artificial colouration of specific target tissue structures, intra/extracellular elements and/or infectious microorganisms, in a clinical specimen, for their subsequent visualization, examination, identification and/or differentiation.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
082930884
Device count
12
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
true
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
10849832001314Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
10849832012211Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
10849832012440Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00849832001317Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00849832012443Leica BiosystemsLeica Biosystems Richmond, Inc.KEQ2025-07-20
00673693168052EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693168069EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180733EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180740EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180757EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180764EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180771EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693180832EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693218511EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693228695EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235969EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235976EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693235990EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693236010EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00673693236027EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEQ2024-08-02
00810047421061N/AScientific Device Laboratory, Inc.KEQ2023-01-31
00810047420323N/AScientific Device Laboratory, Inc.KEQ2023-01-30
00613647023778FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEQ2022-12-07
20613647023772FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.KEQ2022-12-07
10615233078657Tissue-Tek®SAKURA FINETEK U.S.A., INC.KEQ2019-12-15