CE Approved Singclean Ivd Rapid AG Diagnostic Igg/Igm Antibody Test Device for Infectious Disease

• Customization: Available
• Type: IVD Reagent
• Model No.: Cassette/Card/Device
• Model NO.: Antibody
• Speciems: Human Wholeblood, Serum or Plasma.
• Packing: Box, Carton
• Feature 1: Fast Results in 2-15 Minutes
• Feature 2: One Step Disinfection Tablets and Lancets
• Feature 3: High Sensitivity and Specificity
• Transportation: by Sea, by Air and by Delivery
• Transport Package: Carton
• Specification: 1 test/box, 20 tests/box
• Trademark: Singclean
• Origin: China Mainland
• HS Code: 3002190000
• Production Capacity: 10, 0000PC /Month

Product Description

High Sensitivity Blood/Serum/Plasma Igg/Igm Antibody Test
IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is an assay for the rapid, qualitative and differential detection of IgG and IgM antibodies to C-19 in human wholeblood, serum or plasma.

The fast test cassette, part of the kit, can detect the virus in just 10-15 minutes.

The test kit can shorten the testing time, provide easier and faster operation and make rapid diagnosis of suspected patients and on-site screening of people in close contact.

MATERIALS SUPPLIED
 

Specification	Package Contents	Carton
20 tests/kit	1 Instruction 5 Buffers 20 Test Kits 20 Lancets 20 Disposable Micropipettes 20 Alcohol Tablets	600 pcs, L650*W270*H370mm, 6.88kg
1 test/kit	1 Instruction 1 Buffer 1 Test Kit 1 Lancet with Instruction 1 Disposable Micropipette 1 Alcohol Tablet	500 pcs, L680*W530*H400mm, 15.2kg

MATERIAL REQUIRED BUT NOT PROVIDED
1. Centrifuge (for plasma only)                  
2. Timer
3. Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)

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.

Features & Benefits
• Fast results as soon as 2-15 minutes
• Facilitates patient treatment decisions quickly
• Simple, time-saving procedure
• Little specimens, only 5 μL of serum/plasma or 10 μL of whole blood specimens
• All necessary reagents provided & no equipment needed
• High sensitivity and specificity