AFB staining kit for histology for the detection of acid-fast bacteria in histological tissue

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

AFB staining kit for histology for the detection of acid-fast bacteria in histological tissue

UDI-DI code

04054839999956

Basic UDI-DI

4027269132450V6

Reference / catalog number

1324500001

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 “AFB staining kit for histology - for the detection of acid-fast bacteria in histological tissue” is used for human-medical cell diagnosis and serves the purpose of the histological investigation of sample material of human origin. It is a ready-to-use staining kit that when used together with other in vitro diagnostic products from our portfolio makes bacterial target struc - tures evaluable for diagnostic purposes (e. g. acid-fast bacteria, by fixing, embedding, staining, counterstaining, mounting) in histological specimen materials, for example histological sections of e. g. the lung. The AFB staining kit is based on the Ziehl-Neelsen staining method for the detection of acid-fast bacteria. The set is modified such, that heating of the carbolfuchsin solution is dispensable. Consequently, the release of potentially hazardous phenolic vapors will be avoided. The use of light green solution renders the background color less dominant, making the acid-fast bacteria considerably more visible and thus enhancing the quality of the diagnosis. Unstained structures are relatively low in contrast and are extremely diffi - cult to distinguish under the light microscope. The images created using the staining solutions help the authorized and qualified investigator to better define the form and structure in such cases. Further examinations ma y be necessary to reach a definitive diagnosis.

Additional information URL

https://www.sigmaaldrich.com/

Clinical sizes

No clinical sizes registered for this device.

• W01030708STAIN SOLUTIONS (HISTOLOGY/CYTOLOGY)

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