Hemacolor® Rapid staining of blood smear Solution 1: fixing solution

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

Hemacolor® Rapid staining of blood smear Solution 1: fixing solution

UDI-DI code

04022536137629

Basic UDI-DI

4027269111955VC

Reference / catalog number

1119552500

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 “Hemacolor® Rapid staining of blood smear - Solution 1: fixing solu - tion” is used for human-medical cell diagnosis and serves the fixing of native blood and bone-marrow smears of human origin. It is a ready-to-use solution that when used together with other in vitro diagnostic products from our portfolio makes target structures evaluable for diagnostic pur - poses (by fixing, staining, counterstaining, mounting) in hematological and clinico-cytological specimen materials, for example smears of whole blood and bone marrow. The fixatives that are appropriate for use from case to case are described in the corresponding instructions for use for in vitro diagnostic staining solu - tions and test kits. 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.

• W0103010302ROMANOWSKY STAINS

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