AFB-Color carbol fuchsin solution for the microscopic investigation of acid-fast bacteria (AFB)(cold staining)

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-Color carbol fuchsin solution for the microscopic investigation of acid-fast bacteria (AFB)(cold staining)

UDI-DI code

04022536557175

Basic UDI-DI

4027269108512VC

Reference / catalog number

1085122500

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-Color carbol fuchsin solution - for the microscopic investigation of acid-fast bacteria (AFB) (cold staining)” is used for human-medical cell diagnosis and serves the purpose of the bacteriological and histological investigation of sample material of human origin. It is a ready-to-use stain - ing solution that when used together with other in vitro diagnostic products from our portfolio makes target structures evaluable for diagnostic purposes (e. g. acid-fast bacteria (AFB)) by fixing, embedding, staining, counterstain - ing, mounting in bacteriological and histological specimen materials, for example smears of enriched bacterial cultures or histological sections of e. g. the lung . 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 tests must be carried out according to recognized, valid methods to reach a definitive diagnosis.

Additional information URL

https://www.sigmaaldrich.com/

Clinical sizes

No clinical sizes registered for this device.

• W0104010804STAINS

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