SAA-002_02

Organization name

AIDA GmbH

SRN

DE-MF-000040784

Manufacturer status

Active

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

• CW010

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

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 8 countries total.

Trade name

not provided

UDI-DI code

04260158683548

Basic UDI-DI

42601586PDDETECTSE

Reference / catalog number

SAA-002_02

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

2

Additional product description

PD DETECT is a fluorescence-based assay for the qualitative detection of Lewy-fold specific α-synuclein protein aggregates in human cerebrospinal fluid (CSF). The assay is an aid to diagnosis of α-synucleinopathies such as Parkinson’s disease (PD), Parkinson’s Disease Dementia (PDD) and Lewy Body Dementia (DLB). The assay is used in patients with clinical indications of α-synucleinopathies. The assay is processed manually and intended for professional use only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01019099CLINICAL CHEMISTRY REAGENTS - OTHER

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Certificate health across this manufacturer's portfolio.