FDA.reportPublic FDA data

Leica Biosystems

Primary DI
10849832023064
Brand
Leica Biosystems
Company
Leica Biosystems Richmond, Inc.
Model
000000000003801575
Device description
Hematoxylin 560MX
Published
2024-12-16
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
HYJHEMATOXYLIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HYJHematoxylinHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10849832023064PrimaryGS10
00849832023067Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1084983202306410849832023064
00849832023067008498320230678498320230670849832023067

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)5374669tech.support@Leicabiosystems.com
+1(866)4783999tech.support@Leicabiosystems.com

Regulatory Flags#

DUNS number
082930884
Device count
4
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
04015630972135Hematoxylin IIVentana Medical Systems, Inc.HYJ2025-12-15
B502BSB03601000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB036010000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB0360150Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB03602000Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
B502BSB0360500Pink Hematoxylin CounterstainerBIO SB, INC.HYJ2025-03-18
08435421273498Contrast Hematolxylin HDH3VITRO SAHYJ2025-02-20
08435804516624Contrast Hematolxylin HDH3VITRO SAHYJ2025-02-20
00849832027171Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-20
00849832027041Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-19
20849832018081Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00849832018087Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00000000000000Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
00849832018049Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00849832020783Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
00849832022817Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-15
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00673693087995EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693088008EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03