FDA.reportPublic FDA data

Leica Biosystems

Primary DI
10849832012532
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
000000000003801470
Device description
Formula R
Published
2024-12-19
Public version status
Update
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
10849832012532PrimaryGS10
00849832012535Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084983201253210849832012532
00849832012535008498320125358498320125350849832012535

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(800)5374669tech.support@Leicabiosystems.com
+1(866)4783999tech.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
00849832028345Leica Biosystems380365538036552026-10-13
10849832018619Leica Biosystems380077038007702026-10-13
10849832020360Leica Biosystems380079038007902026-10-13
10849832022968Leica Biosystems3800840E3800840E2026-10-13
10849832024122Leica Biosystems380078038007802026-10-13
10849832024153Leica Biosystems3800780AS3800780AS2026-10-13
10849832024306Leica Biosystems380081038008102026-10-13
10849832024368Leica Biosystems3800754AS3800754AS2026-10-13
10849832026904Leica Biosystems380084038008402026-10-13
20849832020343Leica Biosystems380081027AS380081027AS2026-10-13
20849832020350Leica Biosystems3800790BLK3800790BLK2026-10-13
20849832020695Leica Biosystems3800771BLK3800771BLK2026-10-13
20849832023092Leica Biosystems380075938007592026-10-13
20849832024105Leica Biosystems380079024AS380079024AS2026-10-13
20849832024112Leica Biosystems3800754BLK3800754BLK2026-10-13
20849832024396Leica Biosystems380075432AS380075432AS2026-10-13
20849832025676Leica Biosystems380077124AS380077124AS2026-10-13
00849832023036Leica Biosystems380085038008502026-10-12
00849832023043Leica Biosystems380085438008542026-10-12
00849832023050Leica Biosystems380085238008522026-10-12

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
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
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