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EUDAMED last updated this device on May 25, 2026
B-06936155803774ONE STEP Myoglobin 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.
06936155803774ITP08003-TC40(01)06936155803774
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160702MYOGLOBIN - RT & POC5 warnings recorded — scroll inside the panel to see all entries.
Do not use the test card if it has become wet or if the foil pouch is damaged.
Do not use kit reagents beyond their expiration dates.
For professional in vitro diagnostic use only. The test result should be used in conjunction with other clinical information such as clinical signs/symptoms and other test results, and diagnostic decisions should not be based on a single test result alone. Do not interchange kit reagents from different lots.
Read and follow the package insert carefully before use.; Biological risks: Treat all samples as potentially infectious. Wear gloves and protective clothing when handling samples, clean and disinfect spills using a suitable disinfectant, dispose of biohazardous materials according to standard safety precautions, and sterilize all kit reagents used in the assay before disposal.
Do not re-use the test card or any single-use accessories.
Primary placement in Bulgaria; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| BulgariaPrimary placement | — | Still on market |
CN-MF-000023625Sterile
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.
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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.