Anti-Chlamydia trachomatis IgM Abs.

Organization name

ORGENTEC Diagnostika GmbH

SRN

DE-MF-000033178

Manufacturer status

Active

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• CW010

  EUDAMED did not publish a description for this code.
• CW267

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• CW132

  EUDAMED did not publish a description for this code.

Primary placement in Germany; available across 1 country total.

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

Trade name

Anti-Chlamydia trachomatis IgM Abs.

UDI-DI code

04260157083561

Basic UDI-DI

B-04260157083561

Reference / catalog number

ORG 906MX

Issuing entity

GS1

Risk category

IVDD — Annex II List B

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

"Anti-Chlamydia trachomatis IgM Abs. for Alegria® is an ELISA-based test system for the quantitative measurement of IgM class antibodies against Chlamydia trachomatis in human serum or plasma samples. This product is intended for professional in vitro diagnostic use only. The Alegria® Anti-Chlamydia trachomatis IgM Abs. offers test strips with integrated rheumatoid factor (RF) absorbent. 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.

• W0105010111CHLAMYDIA TRACHOMATIS ANTIBODY IGM

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