Organization name

One Lambda, Inc.

SRN

US-MF-000024901

Manufacturer status

Active

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

• CW010

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

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

SeCore™ A Locus Sequencing Kit

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.

00814695022823

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.

081469502SECGZ

Reference / catalog number

22000D

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 SeCore™ HLA Sequencing System is an in vitro diagnostic medical device intended to be used by trained healthcare professionals for qualitative typing of HLA Class I (HLA-A, -B and -C loci) and HLA Class II (DPB1, DQB1 and DRB loci) alleles on sanger sequencing, capillary electrophoresis genetic analyzer platforms for screening of the safety and compatibility of tissues with potential transplant recipients. The test is not automated and is intended for HLA typing of DNA extracted from human whole blood specimens

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.

• W01030403HLA ANTIGEN TYPING

• IVDR Class C medical devices in EUDAMED

Certificate health across this manufacturer's portfolio.

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