Human Use New Virus in Vitro Diagnostic Rapid Antigen Test Kit (20test/box)
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Product Highlights
- High Sensitivity and Specificity: Sensitivity reaches 96.64% and specificity achieves 99.10% for accurate results.
- Fast Reaction Time: Delivers results within 15-20 minutes for rapid diagnosis.
- Flexible Customization Options: Offers full, minor, sample-based, and design-based customization services.
- CE and ISO Certified: Meets international safety and quality standards with CE and ISO certifications.
- GMP Compliant Production: Manufactured in a 10,000+ sqm GMP purification workshop ensuring high quality.
- Advanced Technology Platforms: Features proprietary fluorescent staining and time-resolved immunofluorescence tech.
- Strong R&D Team: Led by doctors from top global universities with over 50% R&D personnel.
Product Attributes
- Customization
- Available
- Type
- IVD Reagent
- Certificate
- CE, ISO
- Model NO.
- Antigen Test
- Transport Package
- Box+Carton
- Trademark
- OBM/OEM
- Origin
- China
- HS Code
- 3002150090
- Production Capacity
- 5, 000, 000 Pieces/Month
Product Images of Human Use New Virus in Vitro Diagnostic Rapid Antigen Test Kit (20test/box)
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Product Description
Sensitivity: 96.64%
Specificity: 99.10%
Reaction time: 15-20 min
Storage temperature: 2-30°C
Packing size: 20 tests/kit


About Medomics
Jiangsu Medomics Medical Technology Co., Ltd., is located at Biotech and Pharmaceutical Valley of the National Jiangbei New Area, Nanjing, Jiangsu Province. It is an international high-tech enterprise driven by innovation in the area of medical devices R&D, production and sales. Medomics focuses on diagnosis of microorganisms, tumors and some rare diseases, mainly engaged in the research and development, production and sales of in vitro diagnostic reagents and automatic instruments.
Medomics owns two R&D centers in China and the US, independent intellectual property rights of fluorescent staining technology, protein labeling technology, time-resolved immunofluorescence detection technology, image processing and analysis technology and other innovative technology platforms, as well as a total of more than 10,000 square meters of GMP purification production workshop that meets the product standards of FDA, CE and CFDA. Until now, Medomics has more than 100 employees across the world and R&D personnel accounts for over 50%. Medomics also has a multidisciplinary expert team with abundant experience in the industry, including senior experts in immunology, microbiology, applied physics, polymer materials, medical imaging, optical systems, etc. The members of the technical team are led by doctors from many famous institutions, such as Osaka University, North Carolina University, University of Nebraska Lincoln, Zhejiang University, Sichuan University and other institutions.
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About the Supplier
This supplier has been audited by BV. Verify the report on the official BV website with ID "MIC-ASR244532". Items marked "" are certified.
Company Profile
Jiangsu Medomics Medical Technology Co., Ltd., is located at Biotech and Pharmaceutical Valley of the National Jiangbei New Area, Nanjing, Jiangsu Province. It is an international high-tech enterprise driven by innovation in the area of medical devices R&D, production and sales. Medomics focuses on diagnosis of microorganisms, tumors and some rare diseases, mainly engaged in the research and development, production and sales of in vitro diagnostic reagents and automatic instruments.
Medomics owns two R&D centers in China and the US, independent intellectual property rights of fluorescent staining technology, protein labeling technology, time-resolved immunofluorescence detection technology, image processing and analysis technology and other innovative technology platforms, as well as a total of more than 10, 000 square meters of GMP purification production workshop that meets the product standards of FDA, CE and CFDA. Until now, Medomics has more than 100 employees across the world and R&D personnel accounts for over 50%. Medomics also has a multidisciplinary expert team with abundant experience in the industry, including senior experts in immunology, microbiology, applied physics, polymer materials, medical imaging, optical systems, etc. The members of the technical team are LED by doctors from many famous institutions, such as Osaka University, North Carolina University, University of Nebraska Lincoln, Zhejiang University, Sichuan University and other institutions.
Medomics developed IgM/IgG antibody detecting kit with the team of Zhong Nanshang. And Medomics published the first research paper on international journal together with State Key Laboratory of Respiratory Disease (National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health). The detecting kit was validated by CDC, Harvard Medical School and Columbia University Irving Medical Center etc. Until May 2020, the kit has been exported to dozens of countries and areas, making great help.
At present, Medomics's series product have been developed according to ISO 13485 Quality system and European CE Certification.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- 3 / F, Building D, Phase Ii, Zhongdan Ecological Life Science Industrial Park, 3-1 Xinjinhu Road, Jiangbei New District, Nanjing, Jiangsu, China
-
Plant Area
- 12871.57 square meters
-
Number of Employees
- 156
-
Registered Capital
- 25,519,651 RMB
-
Terms of Payment
- LC, T/T, D/P, PayPal, Western Union, Small-amount payment
-
International Commercial Terms(Incoterms)
- FOB, CIF, CFR, EXW
-
Average Lead Time
-
Peak Season Lead Time: within 15 workdays
Off Season Lead Time: within 15 workdays -
Nearest Port
- Shanghai Port
-
Minimum Order Quantity
- 1 Set
-
Supply Chain Partners
- 28
Our Production Capability & Technical Expertise
-
Main Products
- In Vitro Diagnostics
-
Production Lines
- 1
-
Production Machines
- Auto Processing Line
-
QA/QC inspectors
- 4 people
-
Inspection Type for Finished Products
- Random inspection(Visual inspection & Function inspection)
-
Inspection Method for Finished Products
- Have instructions and uniformly followed
-
Customization Options
- Customization from Samples, Customization from Designs, Full Customization, Minor Customization, Flexible customization
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 42 people
-
Traceability of Raw Materials
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2017-10-12
-
Export Year
- 7 Years
-
Main Markets
- Southeast Asia/ Mideast, Africa, Australia
-
Repeat Buyers Choice
- 80%~100%
-
Number of Foreign Trading Staff
- 6
-
Overseas Agent/Branch
- No
-
New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
-
Cooperated with Fortune 500
- No
FAQ
- What is the sensitivity and specificity of the test?
- The test kit features a sensitivity of 96.64% and a specificity of 99.10%.
- How long does the test take to complete?
- The reaction time is between 15 to 20 minutes.
- Is customization available for this product?
- Yes, we offer full customization, minor customization, and customization from samples or designs.
- What certifications does the product hold?
- The product holds CE and ISO certifications.
- What is the minimum order quantity?
- The minimum order quantity is 1 set.
- What are the payment terms accepted?
- We accept LC, T/T, D/P, PayPal, Western Union, and small-amount payments.
- What is the lead time for production?
- The average lead time is within 15 workdays for both peak and off-peak seasons.
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