MosaiQ® AiPlex CTDplus Quality Controls XL

Organization name

AliveDx Suisse SA

SRN

CH-MF-000024025

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.
• CW008

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

  May produce an allergic reaction.-(Description)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 7 countries total.

Trade name

MosaiQ® AiPlex CTDplus Quality Controls XL

UDI-DI code

07640327462094

Basic UDI-DI

764032746AIPLEXCTDPLUQCP8

Reference / catalog number

132003

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 CTDplus Quality Controls XL (CTDplus QCs XL) are intended to be used as unassayed controls with procedures for determination of autoimmune antibodies within automated systems. The products are intended for professional use within a clinical laboratory for the qualitative screening of antibodies to native dsDNA, Sm, Sm/RNP, TRIM21, SS-A 60, SS-B, U1RNP, CENP-B, Scl70, Jo1, Ribosomal P Protein, Chromatin, CCP2, RNA Polymerase III and DFS70 in human serum samples.

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