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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

Anti-Chlamydia trachomatis IgG — IVDD — Annex II List B IVDD

MD Atlas
ORGENTEC Diagnostika GmbH

EUDAMED last updated this device on Nov 21, 2025

Anti-Chlamydia trachomatis IgG

B-04260157083530

On the marketIVDD — Annex II List B

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: ORGENTEC Diagnostika GmbH
UDI-DI code: 04260157083530
Reference / catalog number: ORG 906G

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Manufacturer information

Organization name: ORGENTEC Diagnostika GmbH
SRN: DE-MF-000033178
Manufacturer status: Active

Critical warnings

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

CW010
EUDAMED did not publish a description for this code.
CW267
EUDAMED did not publish a description for this code.
CW263
EUDAMED did not publish a description for this code.
CW132
EUDAMED did not publish a description for this code.

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: Anti-Chlamydia trachomatis IgG
UDI-DI code: 04260157083530
Basic UDI-DI: B-04260157083530
Reference / catalog number: ORG 906G
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: "Anti-Chlamydia trachomatis IgG for Alegria® is an ELISA-based test system for the quantitative measurement of IgG class antibodies against Chlamydia trachomatis in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. After primary infection, IgM, IgA, and IgG antibodies can be detected successively in serum samples. IgG antibodies are generally considered as markers for any contact with the pathogen irrespective of disease stage. Several years after the infection, they may disappear again. IgM antibodies are characteristic for acute Chlamydia infection, and IgA antibodies indicate ongoing progression of a persistent infection."
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105010110CHLAMYDIA TRACHOMATIS ANTIBODY IGG

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Anti-Chlamydia pneumoniae IgAB-04260157083585On the market Anti-Chlamydia pneumoniae IgGB-04260157083578On the market Anti-Chlamydia pneumoniae IgM Abs.B-04260157083608On the market ORG 906AB-04260157083547On the market Anti-Chlamydia trachomatis IgM Abs.B-04260157083561On the market

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.