FDA.reportPublic FDA data

Leica Biosystems

Primary DI
10849832012549
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
000000000003801340
Device description
Tissue Infiltration Medium
Published
2024-12-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
KEOFORMULATIONS, PARAFFIN, ALL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KEOFormulations, Paraffin, AllPathology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849832012549PrimaryGS10
00849832012542Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084983201254910849832012549
00849832012542008498320125428498320125420849832012542

GMDN Terms#

Term, Definition table
TermDefinition
Paraffin-based embedding medium IVDA paraffin-based embedding material intended to be used as an embedding medium in the processing of biological tissues or clinical specimens.

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(866)4783999tech.support@Leicabiosystems.com
+1(800)5374669tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
10
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
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
10849832000973Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2025-02-03
10849832021664Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2025-02-03
00849832000976Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2025-02-03
00849832021667Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2025-02-03
10849832012525Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
10849832012532Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
10849832020476Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
00849832012528Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
00849832012535Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
00849832020479Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-19
10849832000942Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832000966Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832012563Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832012570Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832021626Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832021640Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832000945Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832000969Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832012542Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832012566Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832012573Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832000938Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
00849832021643Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832021428Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-15
10849832021435Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-15
00849832021421Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-15
00849832021438Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-15
00673693568074EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEO2024-10-29
00673693089029EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEO2024-08-14
00673693088992EprediaRICHARD-ALLAN SCIENTIFIC COMPANYKEO2024-08-07