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EUDAMED last updated this device on May 27, 2026
B-06936155806751Rapid SARS-CoV-2 Antigen 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 Netherlands. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.
06936155806751ITP16010-TC1(01)06936155806751
European Medical Device Nomenclature — the EU product classification assigned to this device.
W0105090501CORONAVIRUS ANTIGEN (AG) - RT & POC6 warnings recorded — scroll inside the panel to see all entries.
For in vitro diagnostic use only. This product is for diagnosis of SARS-CoV-2 infection only; other diseases cannot be analyzed with any component of this kit. Positive results should be confirmed using an appropriate test such as RT-PCR or equivalent. Clinical diagnosis of SARS-CoV-2 infection should not be made solely based on this product, and negative results cannot rule out SARS-CoV-2 exposure or infection.
Read and strictly follow the instructions for use before testing. Reliability of assay results cannot be guaranteed if the instructions are not followed.
Strict personal protection is required. Follow good microbiological practices when handling and processing specimens. Wear disposable gloves, avoid touching the face with gloved hands, clean and disinfect contaminated areas, and decontaminate and dispose of specimens, reagents and potentially contaminated materials as infectious waste in a biohazard container.
Do not reuse the cassette, swab or buffer tube/test tube.
CN-MF-000023625Do not use the swab if the package is damaged or the seal is broken, and do not use the test cassette if the foil pouch is damaged or the seal is broken.
Do not use expired reagents or test cassettes.
Primary placement in Netherlands; available across 1 country total.
| Country | On market since | Until |
|---|---|---|
| NetherlandsPrimary 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.
No 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.