CAT Hematoxylin, 500mL

Trade name

CAT Hematoxylin, 500mL

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

View in glossary →

00847627014269

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

View in glossary →

08476270BCHEMATH6

Reference / catalog number

CATHE-M

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

View in glossary →

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

View in glossary →

IVDR Class A

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

"For In Vitro Diagnostic Use CAT Hematoxylin is intended for use by laboratory professional users for the visualization of cellular nuclei in formalin-fixed, paraffin-embedded (FFPE) tissue sections in manual or automated procedures. It is used as a counterstain in immunohistochemical (IHC) and chromogenic in situ hybridization (CISH) applications. It may also be used for routine Hematoxylin and Eosin staining. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls and should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. CAT Hematoxylin is used to visualize cellular nuclei in tissue sections and cellular preparations in pretreated formalin-fixed, paraffin-embedded tissue sections in immunohistochemistry. CAT Hematoxylin is a Mayer’s Hematoxylin (Lillie modification) histological staining reagent for use in the histologic demonstration of nuclear staining. It is also used in special-staining procedures as a counterstain for nuclear demonstration. Hematoxylin solutions contain hematein and a metal mordant. The mordant provides the stain color. In the case of Mayer’s Hematoxylin (Lillie’s modification), the hematoxylin contains aluminum, giving a purple color (Nuclei after Bluing: Blue). This staining technique is used to make the distinction between a normal nucleus and an abnormal one. For histochemical purposes, hematoxylin is commonly used as a progressive stain. Slides are left in the hematoxylin solution only long enough to stain the nuclei. After staining, tissues are blued in water that has been slightly alkalinized."

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01030799HISTOLOGY / CYTOLOGY REAGENTS - OTHER

No certificate specifically references this device's Basic UDI-DI.