472038N-25

Organization name

nal von minden GmbH

SRN

DE-MF-000013321

Manufacturer status

Active

Primary placement in Germany; available across 32 countries total.

Trade name

not provided

UDI-DI code

D-472038N-25AT

Basic UDI-DI

B-472038N-25AT

Reference / catalog number

472038N-25

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

The NADAL® Malaria Pf/Pan Ag 4 Species Test is a lateral flow chromatographic immunoassay for the simultaneous, qualitative detection and differentiation of HRP II (histidinerich protein II) specific to Plasmodium falciparum (P. falciparum) and pLDH (plasmodium lactate dehydrogenase) specific to Plasmodium species (P. falciparum, P. vivax, P. malariae, P. ovale) in human whole blood specimens. The test is intended for use as an aid in the diagnosis of malaria infection and is designed for professional use only. Any specimen found to be reactive with the NADAL® Malaria Pf/Pan Ag 4 Species Test should be confirmed with a supplementary assay, e. g. the microscopic examination of a thin blood smear.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0105090401PLASMODIUM (MALARIA) - RT & POC

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