Anti-Chlamydia pneumoniae IgM Abs.

Organization name

ORGENTEC Diagnostika GmbH

SRN

DE-MF-000033178

Manufacturer status

Active

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.

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 pneumoniae IgM Abs.

UDI-DI code

04260157083608

Basic UDI-DI

B-04260157083608

Reference / catalog number

ORG 907MX

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

• W0105010116CHLAMYDIA PNEUMONIAE ANTIBODY IGM

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification