Hangzhou Aichek Medical Technology Co.,Ltd
| Payment Terms | T/T |
| Supply Ability | negotiable |
| Packaging Details | 40box/carton |
| Storage | 2℃-30℃ |
| Sample Type | Blood |
| User | Professionals |
| Accuracy | 94.67% (95% CI: 91.57%~97.77%). |
| Certificate | CE ISO 13485 |
| Key words | Rapid Antibody Test Kit ISO Qualitative Detection Rapid IgG IgM Test |
| OEM | OEM customized packing avaliable |
| Formats | 25T/box 1T/box |
| Brand Name | Aichek |
| Model Number | COVID-19-G02001A |
| Certification | CE |
| Place of Origin | China |
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Product Specification
| Payment Terms | T/T | Supply Ability | negotiable |
| Packaging Details | 40box/carton | Storage | 2℃-30℃ |
| Sample Type | Blood | User | Professionals |
| Accuracy | 94.67% (95% CI: 91.57%~97.77%). | Certificate | CE ISO 13485 |
| Key words | Rapid Antibody Test Kit ISO Qualitative Detection Rapid IgG IgM Test | OEM | OEM customized packing avaliable |
| Formats | 25T/box 1T/box | Brand Name | Aichek |
| Model Number | COVID-19-G02001A | Certification | CE |
| Place of Origin | China | ||
| High Light | ISO Qualitative Antibody Rapid Test Kit ，25 Packs IgG And IgM Test ，Antibody Rapid Test Kit 25 Packs | ||
For professional and in vitro diagnostic use only.
| Product Name | Rapid Antibody Test Kit ISO Qualitative Detection Rapid IgG IgM Test |
| Formats | Strip(3mm)Device(4mm) uncut sheet |
| Place of Origen | China |
| Specimen | Blood |
| Read Time | 15 minutes |
| Shelf life | 2 years |
| Package | 25 device/box |
| Storage | 2℃-30℃ |
[INTENDED USE]
The COVID-19 IgG/IgM Rapid Test device is a lateral flow chromatographic immunoassay for the qualitative detection of antibodies (IgG and IgM) to Novel coronavirus in human Whole Blood/Serum/Plasma. It provides an aid in the diagnosis of infection with Novel coronavirus.
[COMPOSITION]
The test contains a membrane strip coated with Mouse anti-Human IgM antibody and Mouse anti-Human IgG antibody on the test line, and a dye pad which contains colloidal gold coupled with Novel coronavirus recombinant antigen.
The quantity of tests was printed on the labeling.
Materials Provided
• Test device •Package insert
• Buffer
Materials Required But Not Provided
• Specimen collection container •Timer
[INTERPRETATION OF RESULTS]
Positive: Control line and at least one test line appear on the membrane. The
appearance of IgG test line indicates the presence of Novel coronavirus specific IgG antibodies. The appearance of IgM test line indicates the presence of Novel coronavirus specific IgM antibodies. And if both IgG and IgM line appear, it indicates that the presence of both Novel coronavirus specific IgG and IgM antibodies. The IgM line appears a little weak, not as strong as the IgG line, because the IgM antibody concentration is lower than the IgG antibody in blood.
Negative: One colored line appears in the control region(C). No apparent colored line appears in the test line region.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test device.
Company Details
Business Type:
Manufacturer
Year Established:
2012
Total Annual:
500000-1000000
Employee Number:
150~200
Ecer Certification：
Active Member
Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of... Hangzhou Aichek Medical Technology Co.,Ltd Hangzhou Aichek Medical Technology Co.,Ltd is a high-tech company specialises in manufacturing rapid diagnostic and healthcare products. With five product lines of fertility, infectious diseases, cardiac marker, tumor marker and drug of...
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