23-111-438
Germaine™ Laboratories Rapid Check™ Respiratory Syncytial Virus RSV Antigen Test
Manufacturer: Germaine™ Laboratories
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Control Sets
Positive and Negative
CE Marker
No
DoA Calibrators
No
Sample Type
Nasopharyngeal Swabs, Nasal Aspirates
For Use With (Application)
Testing children less than 6 years old and adults over 60 years.
Quantity
20 tests/kit
CPT Code
87807
Clia Complexity
Waived
Format
Test Kit
Type
RSV Rapid Test
Includes
20 Individually packaged test devices, Nasopharyngeal Swabs with each kit, 1 R1 (Extraction Reagent Solution) 2 mL, 20 Extraction Tubes, 40 Disposable Pipettes, 1 PC (Positive Control Reagent) 1.0 mL, 1 NC (Negative Control Reagent) 1.0 mL, 1 Instructions for Use
Test Time
15 mins.
Related Products
Description
- Rapid, qualitative detection of respiratory syncytial virus fusion protein in nasopharyngeal swabs or nasal aspirate specimens in children less than 6 years and adults over 60
- Intended as an aid in the rapid laboratory diagnosis of acute respiratory syncytial virus infection in patients with such symptoms
- 510(k) Cleared and CLIA Waived for Prescription Use Detection of fusion protein of respiratory syncytial virus Nasopharyngeal swab and nasal aspirate specimen Each kit includes: 20 Individually packaged test devices Nasopharyngeal Swabs with each kit 1 R1 (Extraction Reagent Solution) 2 mL 20 Extraction Tubes 40 Disposable Pipettes 1 PC (Positive Control Reagent) 1.0 mL 1 NC (Negative Control Reagent) 1 Instructions for Use Premier Test Performance: Positive % Agreement: 93
- 9% Negative % Agreement: 97.7%
SAFETY INFORMATION
- ShelfLife : 24 mos. from Manufacture Date