Gram-Color modified (phenol-free)staining kit for Gram staining method on bacteriological smears

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 modified (phenol-free)staining kit for Gram staining method on bacteriological smears

UDI-DI code

04027269017330

Basic UDI-DI

4027269101603TX

Reference / catalog number

1016030001

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 modified (phenol-free) - staining kit for Gram staining method on bacteriological smears” is used for human-medical cell diagno­ sis and serves the purpose of the bacteriological 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 target structures evaluable for diagnostic purposes (Gram-positive or Gram- negative bacteria) by fixing, staining, counterstaining, mounting in bacte­ riological specimen materials, for example smears of body fluids. Gram-Color modified is a staining kit which is used for a modified Gram staining. The Gram-Color modified solutions are modified and designed in such a way that staining can be carried out on the staining rack. 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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