Gram-Color stain set 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

Gram-Color stain set for the Gram staining method

UDI-DI code

04022536137070

Basic UDI-DI

4027269111885VG

Reference / catalog number

1118850001

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 “Gram-Color - stain set for the Gram staining method” is used for human-medical cell diagnosis and serves the purpose of the bacteriologi - cal 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 diagnos - tic purposes (Gram-positive or Gram-negative bacteria) by fixing, stain - ing, counterstaining, mounting in bacteriological specimen materials, e. g. smears of body fluids. The Gram-Color solutions are modified and designed in such a way that staining can be carried out in staining cells, on the staining r ack, and also in automated staining systems. 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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