PPECOV19-25 At-Home Covid Tests

25 Tests/Kit

Categories: ,

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