COVID-19 Rapid Test Kits - FDA
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FlowFlex COVID-19 Antigen Home Test (OTC)
Each Kit Contains:
1 Test cassette
1 Extraction buffer tube
1 Disposable nasal swab
1 Package insert
Specification:
PPA: 93%, NPA: 100%
Sample Type: Nasal swab
Detection Method: Colloidal Gold...
Indicaid COVID-19 Antigen Home Test (OTC)
Each Kit Contains:
2 or 12 Test cassettes
2 or 12 Sterile swabs
2 or 12 Extraction buffer vials
1 Package insert and quick reference guide
Specification:
Relative sensitivity: 96%, Relative sp...
BinaxNow COVID-19 Antigen Self Test (OTC)
Each Kit Contains:
2 Test cassettes
2 Sterile swabs
2 Extraction tubes
2 Buffers
1 Package insert
Specification:
PPA: 96.6%, NPA: 99.3%
Sample Type: Nasal swab
Detection Method: Colloidal Gol...
INDICAID COVID-19 Antigen Rapid Test (POC)
Each Kit Contains:
25 Test cassettes
25 Sterile swabs
25 Extraction buffer vials
1 Package insert and quick reference guide
Specification:
Relative sensitivity: 84.4%, Relative specificity: 97...
Sienna Clarity COVID-19 Antigen Rapid Test (POC)
Each Kit Contains:
25 Test devices
25 Sterile nasopharyngeal swabs
25 Buffer tubes
1 Positive and 1 Negative control swab
1 Work station
1 Package insert
1 Quick start guide
Specification:
Relat...
GenBody COVID-19 Rapid Antigen Test (POC)
Each Kit Contains:
25 Single-use test devices
2 Bottles containing 9 mL of extraction solution
25 Single-use extraction tubes
25 Single-use dropper tips
25 Single-use specimen sampling swabs (ste...
CareStart COVID-19 Rapid Antigen Test (POC)
Each Kit Contains:
20 Test devices
20 Sterile swabs
20 Extraction vials / caps
1 Package insert
Specification:
Relative sensitivity: 88.37%, Relative specificity: 100.0%
Sample Type: Nasophary...