- Role
- Country
- Date of registration
- Address
AU-MF-0000306401434-IVDD-412/2019Chlamydia CEL IFA is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by Cellabs Pty Ltd. Placed on the EU market in Germany. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
EUDAMED last updated this device on May 29, 2026
B-KC1BWPrimary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-KC1BW
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
6 warnings recorded — scroll inside the panel to see all entries.
Consult instruction for use (IFU)
Do not use if packaging is broken or damaged
Do not use past expiry date
Refer to SDS for further information
IVD Use only, professional use only, do not mix components from different kits, reagent has been optimised with Cellabs positive control slide and mounting fluid, Evans Blue dye is a possible carcinogen, avoid contact with skin, patient specimens must be handled as potentially infectious, PCS must be run with each test run,
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.
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.
Primary placement in Germany; available across 12 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Jun 1, 2002 | Dec 1, 2017 |
| Bulgaria | Feb 14, 2017 | Dec 31, 2027 |
| Cyprus | Sep 2, 2020 | Dec 31, 2027 |
| Estonia | May 12, 2017 | Dec 31, 2027 |
| EL | Jan 16, 2017 | Dec 31, 2027 |
| Spain | Jun 1, 2003 | Dec 31, 2027 |
| Hungary | Jan 1, 2005 | Jan 1, 2010 |
| Italy | Jun 1, 2002 | Dec 31, 2027 |
| Lithuania | Apr 1, 2019 | Dec 31, 2027 |
| Latvia | Feb 27, 2019 | Dec 31, 2027 |
| Poland | Sep 15, 2021 | Dec 31, 2027 |
| Slovakia | Oct 27, 2022 | Dec 31, 2027 |
Primary DI
The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.
D-KC1BWBasic UDI-DI
The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.
B-KC1BWKC1UDI issuing entities
Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.
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.
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105010107CHLAMYDIA TRACHOMATIS ANTIGEN DETECTIONNo certificate specifically references this device's Basic UDI-DI.
No 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.