Multi drug Rapid Saliva Test(AMP/BZO/BAR/COC/MET/OPI/PCP/PPX/THC/OXY/KET/BUP/COT/EDDP/6-MAM/MDMA/MTD/TML/K2/FYL/TCA/CBD/ETG/MOR/MQL/LSD/ALC)

Trade name

Multi drug Rapid Saliva Test(AMP/BZO/BAR/COC/MET/OPI/PCP/PPX/THC/OXY/KET/BUP/COT/EDDP/6-MAM/MDMA/MTD/TML/K2/FYL/TCA/CBD/ETG/MOR/MQL/LSD/ALC)

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

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D-697424646DOAS001QHEF

Basic UDI-DI

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.

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B-697424646DOAS001QHEF

Reference / catalog number

MDD-7**2/MDD-7**3/MDD-7**5

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

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EUDAMED

Risk category

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.

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IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

"The Multi drug Rapid Saliva Test is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a portion of the oral fluid specimen migrates upward by capillary action. A drug, if present in the oral fluid specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration in the oral fluid specimen will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region. A drug-positive oral fluid specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative oral fluid specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred."

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0102160511MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT & POC

No certificate specifically references this device's Basic UDI-DI.