Biocard Chlamydia pneumoniae IgM

Organization name

Labsystems Diagnostics Oy

SRN

FI-MF-000018281

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  If the instruction for use is not followed in detail, outcome of the test may be false. Do not reuse tests or accessories. ▪ General laboratory procedures and precautions shall be followed in the handling and disposal of samples and used materials. ▪ Do not use the test if the aluminium pouch is damaged or accessories are broken. ▪ Do not use the test after the expiry date. ▪ After the aluminium pouch has been opened, the test should be carried out within next 20 minutes. ▪ Do not mix reagents or tests from different lots. ▪ The sample buffer contains 0.09 % sodium azide. Avoid contact with the skin. Do not swallow!

Primary placement in Finland; available across 1 country total.

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

Trade name

Biocard Chlamydia pneumoniae IgM

UDI-DI code

06416842034013

Basic UDI-DI

B-06416842034013

Reference / catalog number

3-034-000

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

A simple and reliable rapid test for the detection of IgM antibodies against Chlamydia pneumoniae antigen from serum or fingertip blood sample

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