- Role
- Country
- Date of registration
- Address
EUDAMED last updated this device on May 27, 2026
B-06936155808380ONE STEP Multi-8 DOA 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.
06936155808380ITP06107-DT10(01)06936155808380
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0102160511MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC4 warnings recorded — scroll inside the panel to see all entries.
For professional Medical and Forensic use only and for in vitro diagnostic use only. This test provides preliminary screening results only and is not intended to monitor drug levels or determine quantitative drug levels. Positive results should be confirmed by GC/MS or another appropriate method. Avoid cross-contamination by using a new urine sample cup for each sample and do not interpret results after 8 minutes.
Read and follow the package insert carefully before use.
Properly handle and dispose of residual urine and all used reaction devices in an approved biohazard container.
Do not use the kit beyond the expiration date imprinted on the outside of the foil pouch.
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.
B-06936155807055On the marketOne Step Multi-7 DOA TestB-06936155808366On the marketOne Step Multi-7 DOA TestB-06936155803644On the marketONE STEP Multi-8 DOA TestB-06936155807079On the marketONE STEP Multi-9 DOA TestB-06936155807086On the marketONE STEP Multi-9 DOA TestB-06936155808397On 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.