VCM017

Organization name

Vircell, S.L

SRN

ES-MF-000004099

Manufacturer status

Active

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

• CW010

  EUDAMED did not publish a description for this code.

Primary placement in Spain; available across 32 countries total.

Trade name

not provided

UDI-DI code

08436040326213

Basic UDI-DI

843604032VCM01701CF

Reference / catalog number

VCM017

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

Indirect chemiluminescent immunoassay (CLIA) to test IgG antibodies against Chlamydophila pneumoniae in human serum/plasma. The device is intended to be used with general population with suspected infection or exposure to the microorganism. The test is a qualitative and automated assay, intended to be used as an aid to diagnosis.

Additional information URL

https://www.vircell.com/

Clinical sizes

No clinical sizes registered for this device.

• W0105010115CHLAMYDIA PNEUMONAIE ANTIBODY IGG

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

Certificate health across this manufacturer's portfolio.