Lugol’s solution (diluted iodine-potassium iodide solution) for the Gram staining method

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

Lugol’s solution (diluted iodine-potassium iodide solution) for the Gram staining method

UDI-DI code

04022536557410

Basic UDI-DI

4027269109261VH

Reference / catalog number

1092612500

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

These “Lugol’s solution stabilized with PVP - for the Gram staining method” and “Lugol’s solution (diluted iodine-potassium iodide solution) - for the Gram staining method” are used for human-medical cell diagnosis and serve the purpose of the bacteriological investigation of sample material of human origin. They are ready-to-use solutions these when used together with other in vitro diagnostic products from our portfolio make bacte - rial target structures evaluable for diagnostic purposes (Gram-positive or Gram-negative bacteria) by fixing, staining, counterstaining, mounting in bacteriological specimen materials, e. g. smears of body fluids. 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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