- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jul 4, 2024
B-06438172215016Chlamydia trachomatis IgA EIA is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by Labsystems Diagnostics Oy. Placed on the EU market in Finland. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
064381722150166111111(01)06438172215016
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105010109CHLAMYDIA TRACHOMATIS ANTIBODY IGA1 warning recorded — scroll inside the panel to see all entries.
All human materials used in the preparation of the calibrators/controls in the kit have been tested for the presence of the antibodies to HIV (Human Immunodeficiency Virus) and HCV (Hepatitis C Virus) as well as Hepatitis B surface antigen (HBsAg) and found to be non-reactive. Because no test method can offer complete assurance that HIV, hepatitis B virus, HCV, or other infectious agents are absent, these calibrators and controls as well as samples should be handled at the Biosafety level 2 as recommended for any potentially infectious human serum or blood sample in the Centers for Disease Control/National Institutes for Health Manual, “Biosafety in Microbiological and Biomedical Laboratories,” 2007
FI-MF-000018281C-02-1172-794-22Primary placement in Finland; available across 1 country total.
Placed on the market in Finland; per-country availability dates not published.
Sterile
A sterile device is supplied free of viable micro-organisms — flagged so that it is handled, stored and used to preserve that sterile state.
View in glossary →Single-use device
A single-use device is intended to be used on one patient during a single procedure and then discarded — not reprocessed or reused.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →Basic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
View in glossary →UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
View in glossary →IVDR risk classes
IVDR risk classes rank in-vitro diagnostic devices from lowest risk (Class A) to highest (Class D), based on the patient and public-health risk of a wrong result.
View in glossary →Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
View in glossary →No certificate specifically references this device's Basic UDI-DI.
B-06438172124011On the marketChlamydia pneumoniae IgG EIAB-06438172123014On the marketChlamydia pneumoniae IgM EIAB-06438172125018On the marketChlamydia trachomatis IgG EIAB-06438172212015On the marketCOVID-19 Real Time Multiplex RT-PCR KitB-06438172312029On the marketCOVID-19 Real Time Multiplex RT-PCR KitB-06438172312012On the marketNo 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.