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EUDAMED last updated this device on May 27, 2026
B-06936155803835Rapid Mycoplasma Pneumoniae IgM test is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — General. Manufactured by InTec PRODUCTS, INC.. Placed on the EU market in Bulgaria. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06936155803835ITP15001-TC40(01)06936155803835
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105010802MYCOPLASMA ANTIBODY ASSAYS4 warnings recorded — scroll inside the panel to see all entries.
For in vitro diagnostic use only. The test is intended only for detection of MP-IgM in human serum or plasma and provides preliminary analysis results only. Test results should not be used as the only basis for clinical diagnosis. Perform the test under controlled conditions, avoid high humidity and high temperature, use a new and clean plastic pipette to avoid cross-contamination, and do not interpret results after 20 minutes.
Read the package insert carefully before use and strictly follow the instructions.
For testing suspected infected samples, conduct testing within a biosafety cabinet where appropriate. Wear gloves, do not transfer samples by mouth, do not smoke, eat, drink, put on make-up or handle contact lenses during testing, disinfect spilled samples or reagents, and handle and dispose of samples and used materials according to applicable regulations.; Do not re-use: This is a single-use rapid test. Do not re-use the test kit.
Do not use expired test kits.
CN-MF-000023625Primary placement in Bulgaria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| BulgariaPrimary placement | — | Still on market |
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 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.B-06936155804443On the marketRapid Malaria Test (P.f/Pan)B-06936155806843On the marketRapid Malaria Test (P.f/Pan)B-06936155803736On the marketRapid Rota-Adenovirus Combo TestB-06936155803859On the marketRapid Rotavirus TestB-06936155803637On the marketRapid SARS-CoV-2 Antigen TestB-06936155806768On the marketNo certificate specifically references this device's Basic UDI-DI.