Organization name

One Lambda, Inc.

SRN

US-MF-000024901

Manufacturer status

Active

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

• CW011

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

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 32 countries total.

Trade name

LinkSēq HLA-B27 Typing 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.

00814695025602

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.

081469502LNQHM

Reference / catalog number

8011C-SL

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 LinkSēq HLA Typing Test is a qualitative assay for in vitro diagnostic use, bytrained healthcare professionals, for HLA Typing of Class I and Class II alleles (A, B, C, DRB1, D R3/4/5, DQA1, DQB1, DPA1, and DPB1 loci) on real time polymerase chain reaction (real-time PCR) instrument platforms for screening of the safety and compatibility of tissues with potential transplant recipients. The test is not automated and is for HLA typing of DNA extracted from human whole human 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

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

Certificate health across this manufacturer's portfolio.