DPX new non-aqueous mounting medium for microscopy

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

DPX new non-aqueous mounting medium for microscopy

UDI-DI code

04027269296575

Basic UDI-DI

4027269100579UL

Reference / catalog number

1005790500

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 ready-to-use anhydrous mounting media are suited for mounting dehydrated sample material of human origin after these have been fixed and embedded as necessary, and then histologically, bacteriologically, he - matologically (enzyme-cytochemically), or cytologically stained and, where applicable, counterstained with other in vitro diagnostic products from our portfolio, thus making them evaluable for further diagnostic procedures. Samples are mounted on slides to enable the specimen material to be examined by light microscopy, at the same time preserving it and thus enabling it to be re-examined many years later. The appropriate anhydrous mounting medium for the respective application is given in the corresponding instructions for use for our In Vitro Diagnostic staining solutions, solid dyes, and test kits. Using the auxiliary reagents from our portfolio creates the conditions that enable authorized and qualified investigators to make a correct diagnosis at the end of the diagnostic process. In this regard, auxiliary IVD reagents serve inter alia to process human specimen material (e. g. fixing, decalcify - ing, dehydrating, clarifying, paraffin-embedding, mounting, microscoping, archiving). When used together with the corresponding staining solutions, this enables the visualization of cellular structures that are otherwise low in contrast, thus rendering them evaluable under the optical microscope. Further examinations may be necessary to reach a definitive diagnosis.

Additional information URL

https://www.sigmaaldrich.com/

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01030706MOUNTING MEDIA (HISTOLOGY/CYTOLOGY)