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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Organization name
UDI-DI code
Reference / catalog number

HLA-Ready Gene B57 — IVDD — Annex II List B IVDD

MD Atlas
inno-train Diagnostik GmbH

EUDAMED last updated this device on Feb 4, 2026

HLA-Ready Gene B57

B-04260152483137

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: inno-train Diagnostik GmbH
UDI-DI code: 04260152483137
Reference / catalog number: 002 062 032

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Manufacturer information

Organization name: inno-train Diagnostik GmbH
SRN: DE-MF-000024702
Manufacturer status: Active

Market distribution

Primary placement in Germany; available across 1 country total.

Placed on the market in Germany; per-country availability dates not published.

Device identification

Trade name: HLA-Ready Gene B57
UDI-DI code: 04260152483137
Basic UDI-DI: B-04260152483137
Reference / catalog number: 002 062 032
Issuing entity: GS1

Classification

Risk category: IVDD — Annex II List B
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: HLA-Ready Genes B57 serves as companion diagnostic and is intended for molecular genetic screening of HLA-B*57:01 from DNA based on the SSP-PCR principle to support the diagnosis of hypersensitivity reaction to abacavir sulfate. HLA-Ready Gene B57 is performed manually and provides qualitative results.
Additional information URL: https://www.inno-train.de/login/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W010699GENETIC TESTS - OTHER

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.