132020

Organization name

AliveDx Suisse SA

SRN

CH-MF-000024025

Manufacturer status

Active

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

• CW008

  EUDAMED did not publish a description for this code.
• CW010

  EUDAMED did not publish a description for this code.
• CW129

  Contains Mixture, 3(2H)-isothiazolone, 5-chloro-2-methyl- with 2-methyl-3(2H)-isothi-azolone. May produce an allergic reaction.

Primary placement in Netherlands; available across 3 countries total.

Trade name

not provided

UDI-DI code

07640327462216

Basic UDI-DI

764032746AIPLEXVASQC7Q

Reference / catalog number

132020

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

1

Additional product description

The MosaiQ® AiPlex VAS Quality Controls are multianalyte, unassayed quality control materials derived from pooled human sera containing IgG antibodies against Myeloperoxidase (MPO), Proteinase 3 (PR3), and Glomerular Basement Membrane (GBM). The controls are intended for use by professional users in clinical laboratories to support the internal quality control procedures of immunoassays detecting these analytes. These materials are unassayed, it is the responsibility of the user to establish appropriate ranges and verify suitability for the specific test system and laboratory conditions.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102152011CONTROLS FOR AUTOIMMUNITY

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