Organization name

One Lambda, Inc.

SRN

US-MF-000024901

Manufacturer status

Active

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

• CW074

  EUDAMED did not publish a description for this code.
• CW078

  EUDAMED did not publish a description for this code.
• CW086

  EUDAMED did not publish a description for this code.
• CW099

  EUDAMED did not publish a description for this code.
• CW102

  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.
• CW010

  EUDAMED did not publish a description for this code.
• CW999

  STOT SE 1 – Specific Target Organ Toxicity Single Exposure Category 1 Aquatic Chronic 1 – Aquatic Chronic Toxicity Category 1 Aquatic Acute 1 – Aquatic Acute Toxicity Category 1 Acute Tox 2 – Acute Toxicity Category 2

Primary placement in Germany; available across 32 countries total.

Trade name

LABScreen™ PRA Class I

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.

00812117011561

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.

081211701LSLJ

Reference / catalog number

LS1PRA

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

LABScreen™ products are in-vitro diagnostic devices for use by trained healthcare professionals for the qualitative detection of Anti-HLA Class I (HLA-A, B, C, MICA) and Anti-HLA Class II (HLA-DR, DQ, DP) antibodies on Luminex instrument platforms for transplant screening and monitoring. The test is not automated and provides histocompatibility data through the analysis of serum and plasma 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.