CNAME
Manufactured by CMANU, Italy
Device identification number
3922
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Fully automated (robot)
Physical Support
Biochip
Target type
Antibody
Antibody type
Polyclonal
Targets
angiotensin-converting enzyme 2
Specimen
Bronchoalveolar lavage fluid
Cross-reactivity (pathogens tested)
Adenovirus Subtype B
Pathogens detected
Adenovirus
Lineages detected
A.23.1
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
12 minutes
Subclass
Sandwich
Detection Principle
Colloidal gold
LOD
12 copies/sample
False positives
12 cpr/cpu
False negatives
12 cpr/cpu
The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements