FDA.reportPublic FDA data

Leica Biosystems

Primary DI
00849832020479
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
000000000003801360
Device description
Blue Ribbon
Published
2024-12-19
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
KEOFORMULATIONS, PARAFFIN, ALL

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849832020476PrimaryGS10
00849832020479Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084983202047610849832020476
00849832020479008498320204798498320204790849832020479

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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
082930884
Device count
10
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
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
10849832000942Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832000966Leica BiosystemsLeica Biosystems Richmond, Inc.KEO2024-12-18
10849832012549Leica 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