Description
Product Information: IMMUNOBIO 4-in-1 SARS-CoV-2 Antigen Rapid Test
Packaging: 20 tests per pack
Intended Use: For the qualitative detection of N-protein antigens related to the novel coronavirus SARS-CoV-2 in throat and nasal secretions
Test Result Time: 15 minutes
Sensitivity: 94.12% (95% CI: 91.04% – 96.21%)
Specificity: 99.75% (95% CI: 98.45% – 99.99%)
Components:
– 20 antigen test cassettes
– 20 extraction tubes with caps
– 20 extraction reagents
– 20 sterile swabs (thin)
– 20 sterile swabs (thick)
– 20 spitting containers
– 20 pipettes
– 1 sample rack
– 1 instruction manual
4 different test types in one box: Throat / Nasopharynx / Anterior Nasal / Saliva
Storage: Store at 2 – 30°C
Shelf Life: 18 months, use within one hour after opening the pouch
Sample Collection: Oropharyngeal, Nasopharyngeal, Anterior nasal, Saliva / Sputum
Detection Limit:
LoD N-Protein: 0.2 to 0.5 ng/ml
LoD SARS-CoV-2 Virus (inactivated): 2-5×10² TCID50/ml
ISO Certification: ISO 13485:2016
Applicable Standard: Directive 98/79/EC for In-Vitro Diagnostics
Manufacturer: Hangzhou Immuno Biotech Co., Ltd.
Who Can Purchase the Antigen Rapid Test?
According to the Medical Devices Distribution Regulation, rapid tests can only be supplied to doctors, healthcare facilities, schools, wholesalers, pharmacies, health authorities, blood donation services, pharmaceutical companies, and consulting/testing facilities for particularly vulnerable groups. We do not sell to end consumers!
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