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EUDAMED last updated this device on May 29, 2026
B-KC3C2Chlamydia CEL PN 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.
AU-MF-0000306401434-IVDD-412/2019D-KC3C2
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA support is coming.
4 warnings recorded — scroll inside the panel to see all entries.
Do not use if packaging is damaged
For in vitro diagnostic use only. Do not use after the expiry date shown on the label. If protective packaging is damaged, contact your local distributor and ask for a replacement. Do not mix components from different kits. The Chlamydia Cel Pn MAb Reagent and Anti-mouse Ig-FITC Reagent have been optimised for use with Cellabs Positive Control Slide and Mounting Fluid. Evans Blue dye contained in the anti-mouse Ig-FITC reagent is a possible carcinogen, therefore avoid contact with the skin. Patient specimens and the positive control slide should be handled as though potentially infectious. A Positive Control Slide must be run with each test run. Refer to Material Safety Data Sheet (MSDS) for further information. For professional use only. To be used with confirmatory testing guidelines or standard quality assurance protocols for clinical samples.
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 7 countries total.
| Country | On market since | Until |
|---|---|---|
| GermanyPrimary placement | Mar 26, 2002 | Dec 31, 2027 |
| Spain | Apr 10, 2002 | Dec 31, 2027 |
| Hungary | May 18, 2007 | Dec 31, 2027 |
| Italy | Jan 3, 2003 | Dec 31, 2027 |
| Poland | Nov 28, 2008 | Dec 31, 2027 |
| Portugal | Apr 16, 2004 | Dec 31, 2027 |
| Slovakia | Nov 4, 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-KC3C2Basic 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-KC3C2KC3UDI 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.
W0105010112CHLAMYDIA PNEUMONIAE ANTIGEN DETECTIONPrimary 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.
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.