FDA.reportPublic FDA data

Contrast Hematolxylin HDH3

Primary DI
08435804516624
Brand
Contrast Hematolxylin HDH3
Company
VITRO SA
Model
MAD-HDH3-100VSBC
Published
2025-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
08435804516624PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435804516624084358045166248435804516624

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
466076718
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08435804523417Master Polymer Plus Detection System (Phosphatase)MAD-000230QKVSBC2026-04-07
08435804524551Master Polymer Plus Detection System (Phosphatase)MAD-000230QKVS2026-04-07
08435804522199FISH PT KITMAD-004082VS2026-01-15
08435804522212DEWAX-2 FISHMAD-004081VS2026-01-15
08435804522366FISH PT KITMAD-004082VSBC2026-01-15
08435804522397DEWAX-2 FISH MAD-004081VSBC2026-01-15
08435804520706Pepsin for antigen retrieval (RTU)MAD-024081RVS2025-08-08
08435804520713Proteinase K (RTU)MAD-011892QEVS2025-08-08
08435804522328Proteinase K (RTU)MAD-011892QEVSBC2025-08-08
08435804522335Pepsin for antigen retrieval (RTU)MAD-024081RVSBC2025-08-08
08435804522342Master Dual Staining KitMAD-001882QPVS2025-08-08
08435804522359Master Dual Staining KitMAD-001882QPVSBC2025-08-08
08435804518970NeoPATH ProVIT-VS42BC2025-02-20
08435256719499TBS Tween 20 Buffer 10X q.s. 10LMAD-004077R-102025-02-20
08435421271890VitroStainer 42VIT-VS422025-02-20
08435421272927Cleaning Solution 10XMAD-003931CSVS2025-02-20
08435421272934Dewax SolutionMAD-004080VS2025-02-20
08435421272972High-ARMAD-004075VS2025-02-20
08435421273047DAB EnhancerMAD-001560QVS2025-02-20
08435421273085CoverMAD-003983VS2025-02-20

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
00849832027171Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-20
00849832027041Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-19
10849832023064Leica BiosystemsLeica Biosystems Richmond, Inc.HYJ2024-12-16
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
00673693089609EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-06
00673693087926EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
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00673693089807EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693089821EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693210126EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
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00673693483230EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-04
00673693087971EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693087995EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03
00673693088008EprediaRICHARD-ALLAN SCIENTIFIC COMPANYHYJ2024-09-03