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EUDAMED last updated this device on May 26, 2026
B-06936155806874ONE STEP Cannabinoids (THC) 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.
06936155806874ITP06003-DS50(01)06936155806874
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160505CANNABINOIDS - RT & POC3 warnings recorded — scroll inside the panel to see all entries.
For professional in vitro diagnostic use only. This product is designed for detection of cannabinoid in human urine only and provides a preliminary qualitative screening result only. Positive results should be confirmed using an alternate method, preferably GC/MS, and clinical considerations and professional judgment should be applied. The test does not indicate the level of intoxication or monitor drug levels. Avoid cross-contamination of urine samples by using a new urine specimen cup for each sample, and do not interpret results after 8 minutes.
Read and follow the package insert carefully before use.
Do not use the kit beyond the expiration date printed on the outside of the foil pouch.
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 certificate specifically references this device's Basic UDI-DI.
B-06936155803880On the marketONE STEP Buprenorphine (BUP) TestB-06936155806973On the marketONE STEP Cannabinoids (THC) TestB-06936155803590On the marketONE STEP CK-MB TestB-06936155803781On the marketONE STEP Cocaine (COC) TestB-06936155806881On the marketONE STEP Cocaine (COC) TestB-06936155803897On the marketNo 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.