Description
Contents
- 25 Test Devices
- 25 Test Tubes
- 25 Filter Caps
- 25 Swabs
- 1 Instruction For Use
| FDA EUA # | EUA210501 |
| Authorized Settings | Non-Prescription Home Use (Over the Counter) |
| Category | Lateral Flow Immunoassay |
| Time for Result | Read results at 15 mins |
| Sample Type | Mid-Turbinate Nasal Swab (NS) |
| Intended Use | Detection of Antigen from SARS-CoV-2 |
| Prospective Study | -Clinical Sensitivity: 86.7 % (95% CI: 73.8%-93.7%) -Clinical Specificity: 99.8 % (95% CI: 98.7%-100.0%) |
| Serial Screening | Y |
| Variants | Anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation |
| Shelf Life | 12 months |
| Manufactured In | Republic of Korea (South Korea) |
Package Configuration
| Basic Information | |
| Tests per Kit | 25 tests |
| Weight of the Kit | 0.79 lb |
| Kit Dimension (L x W x H) | 7.67 x 5.70 x 3.93 (inch) |
| Shipper Dimension & Arrangement | |
| Kits per Shipper | 24 kits (600 tests) |
| Weight of the Shipper | 22.68 lb |
| Shipper Dimension (L x W x H) | 17.8 x 16 x 16.5 (inch) |
| Arrangement in Shipper | 2 x 3 x 4 |
| Pallet Dimension & Arrangement | |
| Shippers per Pallet | 8 shippers (192 kits – 4,800 tests) |
| Weight of the Pallet | 209.4 lb |
| Pallet Dimension | 40 x 40 x 40 (inch) |
| Arrangement in Pallet | 4 x 2 |
