Borg Decloaker, RTU

Trade name

Borg Decloaker, RTU

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 →

00847627014191

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 →

08476270BAGRETFS

Reference / catalog number

BD1000G1

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

The Borg Decloaker, RTU is designed as a tris-based buffer used in heatinduced antigen retrieval (HIER) of formalin-fixed, paraffin embedded (FFPE) tissues. HIER is the process of heating the slide-mounted specimen material in an antigen retrieval solution, followed by a cooling-off period. Retrieval solutions with paraffin emulsifiers (surfactants) followed by a rinsing reagent can deparaffinize and retrieve tissues, thus eliminating the deparaffinization step with xylenes and alcohols.  Most immunohistochemistry (IHC) specimens are routinely fixed in formalin and, while formalin provides excellent preservation of morphology, it can greatly diminish the sensitivity to IHC. Formalin creates cross-links that alter protein biochemistry and can block antigenic sites. Antigen retrieval is needed to break these cross-links and expose the antigen’s epitope. Biocare’s Antigen retrieval reagents are used in heat-induced antigen retrieval (HIER) of formalin-fixed, paraffin embedded (FFPE) tissues. The antigen retrieval process has many variables, including the target antigen, the antibody, fixation time, and tissue processing as well as the antigen retrieval method. For the HIER method, which is the process of heating the slide-mounted specimen material in an antigen retrieval solution, followed by a cooling-off period, the pH and composition of the retrieval solution are important factors.  The recommended heat source is a digitally controlled pressure cooker. Temperature, pressure, and time can be set, monitored, and recorded with the Biocare Decloaking Chamber NxGen to produce consistent antigen retrieval.

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.

• W01029099IMMUNOCHEMISTRY REAGENTS - OTHER

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