COVID -19 New Coronavirus IgG / IgM Rapid Test Cassette ISO13485 / CE

COVID -19 New Coronavirus IgG / IgM Rapid Test Cassette ISO13485 / CE

MOQ:5000pcs
PRODUCT DESCRIPTION
High Light:

infection blood test

,

bacterial infection blood test

Brand Name New Life
Certification ISO13485,CE
Delivery Time 20-30days
Minimum Order Quantity 5000pcs
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ABOUT US
Orient New Life Medical Co.,Ltd.
Orient New Life Medical Co.,Ltd. manufacturer profile
12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China ,China
5.0
Verified Supplier
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COVID -19 New Coronavirus IgG / IgM Rapid Test Cassette ISO13485 / CE
COVID -19 New Coronavirus IgG / IgM Rapid Test Cassette ISO13485 / CE
MOQ: 5000pcs
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About Us
Orient New Life Medical Co.,Ltd.
Orient New Life Medical Co.,Ltd. manufacturer profile
12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China ,China
5.0
Verified Supplier
Company Name Orient New Life Medical Co.,Ltd.
Business Type: Manufacturer,Exporter
Brands: New Life
No. of Employees: 200~300
Year Established: 2009
Annual Sales: 10,000,000-15,000,000
Company Location 12F,Guting Building,Hefeng Creative Square,No.495 Jiangdong North Road,Ningbo,Zhejiang, China
Factory Location No.1369, Chengnan Road, Jiaxing, Zhejiang, China
China Orient New Life Medical Co.,Ltd. manufacturer profile
China Orient New Life Medical Co.,Ltd. manufacturer profile
China Orient New Life Medical Co.,Ltd. manufacturer profile

Established in 2009, Orient New Life Medical Co., Ltd., is specialized in high-tech biological diagnostic test development, research and production, as well as high-tech medical device development, research and production. New Life has built up two production base, which produce biological diagnostic test and endoscopic medical device respectively. Our products ranged in the following specialties: drug of abuse tests, fertility tests, infectious diseases tests, sexual transmitted diseases tests, tumor markers tests, cardiac markers tests, veterinary tests, and surgical stapler series.

 

NEW LIFE have 3 wholly-owned and joint stock subsidiary companies, including Orient New Life Medical  Co., Ltd., Orient Gene Biotech Co., Ltd., Qianjing Medical Equipment Co., Ltd.

 

Company's core technical team with more than 35 employees,3 doctors and 25 masters. They have many years of famous universities in the United States and pharmaceutical companies engaged in the project research and development, production and marketing, business management experience.Company owns hundreds of grade purification workshop and all level of quality checkout room, equipped with various production and testing equipment.

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PRODUCT DESCRIPTION
High Light:

infection blood test

,

bacterial infection blood test

Place of Origin China
Brand Name New Life
Certification ISO13485,CE
Model Number Cassette
Minimum Order Quantity 5000pcs
Packaging Details 1pc/pouch, 25pcs/box
Delivery Time 20-30days
Payment Terms T/T, Western Union, MoneyGram
Supply Ability 2000000pcs/month
Category Infectious disease
Format cassette
Specimen Blood
Testing time 5-15 minutes
Shelf Life 24 Months
Application COVID-19
Accuracy 80%

 

COVID -19 New Coronavirus IgG / IgM Rapid Test Cassette ISO13485 / CE

Description:

 

Product Name: COVID-19 New Coronavirus IgG/IgM rapid screen Test Cassette

 

Accessories: Instruction for use, buffer, pipette
 

Intended Use:

 

The COVID-19 IgM/IgG Test is used for qualitative detection of novel coronavirus IGM/IGG antibodies in human serum, plasma and whole blood. After infection with the novel coronavirus, the common signs include respiratory symptoms, fever, cough, wheezing and dyspnea, etc. In more severe cases, the infection can lead to pneumonia, severe acute respiratory syndrome, kidney failure and even death. Coronaviruses can be expelled from the body through respiratory secretions, transmitted by oral fluids, sneezing, contact, and by airborne droplets.

 

TEST PRINCIPLE

 

The COVID-19 (Sars-CoV-2) IgM/IgG Test is the colloidal gold labeled rabbit IgG and the novel coronavirus (Sars-CoV-2) antigen, while the nitrocellulose membrane is coated with anti-human IgG and sheep anti-rabbit IgG combined to form a band. The principle of colloidal gold immunochromatography indirect method is used to detect the novel coronavirus (Sars-CoV-2) IgM/IgG antibody in human serum.

 

TEST PROCEDURE

 

1. Bring the pouched test device to room temperature(15-30℃) prior to testing. Do not open pouch until ready

to perform the assay.

2. Remove the test device from the sealed pouch. Lay it on a flat, clean and dry surface.

3. Use the pipette to draw and slowly add 1 drop of whole blood/serum/plasma to the sample well.

4. Hold the buffer vertically and add 1 drop to the sample well. /If using a pipette, change a new one to avoid

cross-contamination. Draw and transfer 2 drops of buffer to the sample well.

5. Interpret test results within 10-15 minutes. Do not interpret after 20 minutes.

Caution: The above interpreting time is based on room temperature range of 15-30℃. If your room temperature is

significantly lower than 15℃, then the interpreting time should be properly increased to 30 minutes.

 

INTERPRETATION OF RESULTS

 

Positive:  Two red lines are visible in the result window. The intensity of the test line may be weaker or darker than that of the control line. This still means a positive result.

Negative: The control line appears in the result window, but the test line is not visible.

Invalid:  If the control line does not appear in the result window, the test results are INVALID regardless of the presence or absence of the line in the test region.

 

 

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