0270127

Organization name

möLab GmbH

SRN

DE-MF-000022941

Manufacturer status

Active

7 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW032

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW999

  Cervical swabs should not be collected during menstrual bleeding.
• CW007

  EUDAMED did not publish a description for this code.
• CW999

  Handle all specimens as potentially infectious material. Observe basic precautions against microbiological hazards during the test procedure and follow the relevant regulations for the disposal of specimens.
• CW999

  Wear protective clothing such as a laboratory coat, eye protection and disposable gloves during the test procedure.

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

D-0270127VL

Basic UDI-DI

B-0270127VL

Reference / catalog number

0270127

Issuing entity

EUDAMED

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Rapid chromatographic immunoassay for the qualitative detection of Neisseria gonorrhoeae antigen from cervical swabs from women and urethral swabs from men. It is intended as an aid in the diagnosis of gonorrhoea infection.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105010201GONOCOCCAL ANTIGEN DETECTION

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