- Organization name
- UDI-DI code
- Reference / catalog number
EUDAMED last updated this device on Jun 17, 2026
B-KP2D7Pneumo CEL Indirect IFA is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by Cellabs Pty Ltd. Placed on the EU market in Portugal. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
D-KP2D7KP2AU-MF-0000306401434-IVDD-412/2019D-KP2D7
DataMatrix generation currently supports GS1-issued UDIs. HIBCC / ICCBBA / IFA support is coming.
2 warnings recorded — scroll inside the panel to see all entries.
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.
consult instructions for use
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 Portugal; available across 7 countries total.
| Country | On market since | Until |
|---|---|---|
| PortugalPrimary placement | Nov 1, 2011 | Dec 31, 2027 |
| Germany | Jan 19, 2016 | Dec 31, 2027 |
| Spain | Jul 21, 2014 | Dec 31, 2027 |
| France | Jan 13, 2014 | Dec 31, 2027 |
| Lithuania | Oct 8, 2020 | Dec 31, 2027 |
| Poland | Sep 16, 2021 | Dec 31, 2027 |
| Türkiye | Oct 18, 2011 | Dec 31, 2027 |
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0104050201PNEUMOCYSTIS JIROVECII (PNEUMOCYSTIS CARINII)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.
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.