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EUDAMED last updated this device on May 26, 2026
B-06936155807000ONE STEP Benzodiazepines (BZO) 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.
06936155807000ITP06006-TC40(01)06936155807000
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160504BENZODIAZEPINES - 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 oxazepam 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 is not suggested for determining the quantitative benzodiazepines level in urine and 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-06936155804528On the marketONE STEP Barbiturates (BAR) TestB-06936155803873On the marketONE STEP Barbiturates (BAR) TestB-06936155806911On the marketONE STEP Benzodiazepines (BZO) TestB-06936155806904On the marketONE STEP Buprenorphine (BUP) TestB-06936155803880On the marketONE STEP Buprenorphine (BUP) TestB-06936155806973On 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.