Formaldehyde solution 4%,buffered, pH 6.9 (approx. 10% Formalin solution) for histology

Organization name

Merck KGaA

SRN

DE-MF-000018777

Manufacturer status

Active

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• CW010

  Consult instructions for use

Primary placement in Germany; available across 1 country total.

Trade name

Formaldehyde solution 4%,buffered, pH 6.9 (approx. 10% Formalin solution) for histology

UDI-DI code

04022536729671

Basic UDI-DI

4027269100496UF

Reference / catalog number

1004969011

Issuing entity

GS1

Risk category

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

This “Formaldehyde solution 4%, buffered, pH 6.9 - (approx. 10% Formalin solution) for histology” is used for human-medical cell diagnosis and serv es the purpose of the histological fixation of sample material of human origin. An optimal fixation in the pre-analytical phase of the histological process is one of the most important preconditions for ensuring the good preserv ation status of the tissue in question and of the structures and macromolecules it contains and thus for enabling a precise histopathological analysis of speci - men material. When used properly, this fixing solution is optimally suited for this purpose. The product is a ready-to-use 4% formaldehyde solution, buffered, pH 6.9, corresponding to a so-called “formalin solution 10%”. The term “10% formalin solution” is a well-established term used in histological circles for solutions of 4% formaldehyde in water. This has historical reasons. Used in conjunction with other in vitro diagnostic products from our port - folio, in the pre-analytical phase of the histological process it serves the purpose of preserving tissue structures and macromolecules, which are of decisive relevance in histopathological analyses. Using the auxiliary reagents from our portfolio creates the conditions that enable authorized and qualified investigators to make a correct diagnosis at the end of the diagnostic process. In this regard, auxiliary IVD reagents serve inter alia to process human specimen material (e. g. fixing, decalcify - ing, dehydrating, clarifying, paraffin-embedding, mounting, microscoping, archiving). When used together with the corresponding staining solutions, this enables the visualization of cellular structures that are otherwise low in contrast, thus rendering them evaluable under the optical microscope. Further examinations may be necessary to reach a definitive diagnosis.

Additional information URL

https://www.sigmaaldrich.com/

Clinical sizes

No clinical sizes registered for this device.

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

• W01030706MOUNTING MEDIA (HISTOLOGY/CYTOLOGY)