AFB-Fluor phenol-freeStaining kit for the examination of acid-fastbacteria with fluorescence microscopy(Auramin-Rhodamine staining)

Organization name

Merck KGaA

SRN

DE-MF-000018777

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW010

  Consult instructions for use

Primary placement in Germany; available across 1 country total.

Trade name

AFB-Fluor phenol-freeStaining kit for the examination of acid-fastbacteria with fluorescence microscopy(Auramin-Rhodamine staining)

UDI-DI code

04022536977386

Basic UDI-DI

4027269101597UV

Reference / catalog number

1015970001

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-Fluor phenol-free - Staining kit for the examination of acid-fast bacteria with fluorescence microscopy (Auramin-Rhodamine staining)” is used for human-medical cell diagnosis and serves the purpose of the bac­ teriological, cytological, and 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 structures evaluable for diagnostic purposes (acid-fast bacteria (AFB)) by fixing, embedding, staining, counterstaining, mounting in bacteriological, cytological, and histological specimen materials, for example smears of enriched bacterial cultures or histological sections of e. g. the lung. The decisive feature of the AFB-Fluor phenol-free staining kit is the pres­ ence of fluorescence dyes in the staining solution. This enables the swift and secure identification of the acid-fast bacteria under the fluorescence microscope. In addition, the staining solution is prepared without potentially hazardous phenol, enhancing the safety of the user. This staining set is supplied ready-for-use in practical dropping bottles and contains all the reagents required for the staining of acid-fast bacteria in smear specimens and in histological tissue specimens. 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

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification