CE Approved Antigen Test Kit for New Virus with High Sensitivity

• Classification: Physiological Functions of Diagnosis and Monitoring Equipment
• Type: Ivd Rapid Test Kit
• Certification: CE, MSDS, ISO13485, Bfarm
• Group: All People
• Transport Package: PP, Carton
• Specification: 4.0mm
• Trademark: OEM
• Origin: China
• HS Code: 3002190090
• Production Capacity: 2000000PCS/Week

Product Description

High Sensitivity CE arrpoved Antigen Rapid Diagnostic Test Kits for new Viruss

One Step  Antigen Rapid Test Cassette (Nasopharyngeal Swab) 1 box(20 pieces/ box ) Composition:
20 Test Cassette
20 Antigen Extract Buffer
20 Antigen Extraction Tube
20 Swab
1 Paper workbench
1 Instruction for use

STORAGE AND STABILITY
The kit can be stored at room temperature or refrigerated (2-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
WARNINGS AND PRECAUTIONS
1. For professional In Vitro diagnostic use only. Do not use after expiration date.
2. This package insert must be read completely before performing the test. Failure to follow the insert gives inaccurate test results.
3. Do not use it if the tube/pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards throughout testing and follow the standard procedures for proper disposal of specimens.
6. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
7. Humidity and temperature can adversely affect results.
8. Do not perform the test in a room with strong air flow, ie. electric fan or strong air-conditioning.