Submission form for nucleic acid - PCR based device | COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Commercial name

Manufacturer device reference/catalogue number

Device Instruction For Use (IFU) URL

Eudamed Device Basic UDI-DI

Eudamed Device UDI identifier (UDI-DI)

Eudamed Device UDI production identifier (UDI-PI)

Manufacturer

Start typing in the box below to search an already submitted manufacturer name. If not present, please write the NEW name in the same box (comma and semicolons are not allowed)

Manufacturer country

Manufacturer E-Mail

Manufacturer website

Eudamed manufacturer ID/SRN

Submitter category

Submitter name

Submitter country

Submitter E-Mail

Submitter website

Eudamed submitter ID/SRN

CE Marking

Commercial status

URL for additional information

Physical support

Format

Specimen

Target type

Targets

Cross-reactivity (pathogens tested)

Pathogens detected

Variants detected

Lineages performances

Please provide here Specificity and Sensibility values in percentages for each lineage detected using the following format: LineageName(Specificity;Sensibility);. Eg. Delta(98;78);Omicron(78,79);

Test Information

Assay

Method

Subclass

Detection principle

Measurement

Self test

Reader required

Rapid diagnostic

Time (minutes)

Subcategory

Performances

Type

Value (only numbers)

Unit

Additional info

Additional information

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