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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Chlamydia Antigen Rapid Test Cassette

Manufactured by Genesprint Group Limited

Device identification number
3138
CE Marking
Yes
HSC common list (RAT)
×No
Target type
Antigen
Targets
envelope protein
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Method
Immunoassay
Time
5 minutes
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.04 %
False negatives
2.01 %
Precision
Evaluated
Accuracy
100 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.95 % (Antigen)
Clinical Specificity
97.98 % (Antigen)
Type of antigen
Envelop protein

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