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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 pneumoniae IgA — IVDD — Annex II List B IVDD

MD Atlas
ORGENTEC Diagnostika GmbH

EUDAMED last updated this device on Nov 21, 2025

Anti-Chlamydia pneumoniae IgA

B-04260157083585

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: 04260157083585
Reference / catalog number: ORG 907A

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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 pneumoniae IgA
UDI-DI code: 04260157083585
Basic UDI-DI: B-04260157083585
Reference / catalog number: ORG 907A
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 pneumoniae IgA for Alegria® is an ELISA-based test system for the quantitative measurement of IgA class antibodies against Chlamydia pneumoniae in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. The tests for the detection of different immunoglobulin classes of anti-Chlamydia antibodies contribute to the differentiation of acute primary (IgM), past (IgG), and primary or repeated infections (IgA) and to the determination of the patient’s immune status."
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0105010114CHLAMYDIA PNEUMONIAE ANTIBODY IGA

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
Expiration date
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Software identification

Related devices

Anti-Chlamydia pneumoniae IgGB-04260157083578On the market Anti-Chlamydia pneumoniae IgM Abs.B-04260157083608On the market ORG 906AB-04260157083547On the market Anti-Chlamydia trachomatis IgGB-04260157083530On 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.