Organization name

One Lambda, Inc.

SRN

US-MF-000024901

Manufacturer status

Active

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

• CW074

  EUDAMED did not publish a description for this code.
• CW103

  EUDAMED did not publish a description for this code.
• CW104

  EUDAMED did not publish a description for this code.
• CW011

  EUDAMED did not publish a description for this code.

Primary placement in Austria; available across 32 countries total.

Trade name

C1qScreen™

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00812117016658

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

081211701C1Q5J

Reference / catalog number

C1Q

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

IVDR risk classes

IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.

IVDR Class C

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The C1qScreen kit is an in-vitro diagnostic medical device intended to be used by trained healthcare professionals for the qualitative detection of complement-binding HLA Class I (HLA-A, B, C) and HLA Class II (HLA-DR, DQ, DP) antibodies on the LABScan 100 and/or LABScan3D instrument platforms for transplant screening and monitoring. The test is not automated and provides histocompatibility data for transplant patients through the analysis of serum samples.

Additional information URL

https://www.onelambda.com/

Clinical sizes

No clinical sizes registered for this device.

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

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W01030402HLA ANTIBODY SCREENING

• IVDR Class C medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.

Certificate health across this manufacturer's portfolio.