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

Immersion oil for microscopy

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

04022536053745

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

4027269104699VT

Reference / catalog number

1046990100

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

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 ready-to-use “Immersion oil - for microscopy” possesses a defined refractive index and hence serves to optimize microscopic examinations of histological, cytological, hematological, and bacteriological specimen material of human origin; after they have been fixed, embedded (wherever necessary), stained, counterstained (wherever necessary), and mounted. The areas of application for the immersion oil are described in the corre - sponding instructions for use for the staining solutions, solid dyes, and test kits from our portfolio offered for in vitro diagnostic methods. 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 investigations may be necessary to arrive at a conclusive 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.

• W010399HAEMATOLOGY / HAEMOSTASIS / IMMUNOHAEMATOLOGY / HISTOLOGY / CYSTOLOGY REAGENTS - OTHER

• IVDR Class A medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.