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UDI-DI code
Reference / catalog number

AFB-Color malachite green… — IVDR Class A IVDR by Merck KGaA

MD Atlas
Merck KGaA

EUDAMED last updated this device on Apr 17, 2026

AFB-Color malachite green (oxalate) solution for the microscopic investigation of acid-fast bacteria (AFB) (cold staining)

4027269110630U6

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Merck KGaA
UDI-DI code: 04022536126357
Reference / catalog number: 1106300500

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Manufacturer information

Organization name: Merck KGaA
SRN: DE-MF-000018777
Manufacturer status: Active

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Consult instructions for use

Market distribution

Primary placement in Germany; available across 1 country total.

Country	On market since	Until
GermanyPrimary placement		Still on market

Device identification

Trade name: AFB-Color malachite green (oxalate) solution for the microscopic investigation of acid-fast bacteria (AFB) (cold staining)
UDI-DI code: 04022536126357
Basic UDI-DI: 4027269110630U6
Reference / catalog number: 1106300500
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: This “AFB-Color malachite green (oxalate) solution - for the microscopic investigation of acid-fast bacteria (AFB) (cold staining)” is used for human- medical cell diagnosis and serves the purpose of the bacteriological inves - tigation of sample material of human origin. It is a ready-to-use staining solution that when used together with other in vitro diagnostic products from our portfolio makes target structures evaluable for diagnostic purposes (acid-fast bacteria (AFB)) by fixing, staining, counterstaining, mounting) in bacteriological specimen materials, for example smears of enriched bacte - rial cultures . 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.

EMDN nomenclature code(s)

W0104010804STAINS

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Safety

Sterile

Single use

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New device

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