Tb Tuberculosis Ab Test Cassette Medomics
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Product Highlights
- High Accuracy Detection: Achieves 98% specificity and 98% sensitivity for TB IgG antibody detection.
- Professional Grade Kit: Designed for professional use to detect antibodies against M. tuberculosis in whole blood.
- CE and ISO Certified: Product holds CE and ISO13485 certifications ensuring quality and safety standards.
- Flexible Customization: Offers full, minor, and flexible customization options based on samples or designs.
- Advanced Technology: Utilizes independent IP in fluorescent staining and time-resolved immunofluorescence detection.
- GMP Production Facility: Manufactured in over 10,000 sqm GMP purification workshop meeting FDA and CE standards.
- Strong R&D Team: Backed by 42 R&D engineers and experts from top universities like Osaka and Zhejiang Univ.
- Fast Lead Time: Average lead time within 15 workdays for both peak and off-season periods.
Product Attributes
- Customization
- Available
- Classification
- Ivd
- Type
- Tuberculosis
- Model NO.
- Tuberculosis
- Certification
- CE, ISO13485
- Transport Package
- Box+Carton
- Trademark
- OBM/OEM
- Origin
- China
- HS Code
- 3002150090
- Production Capacity
- 5, 000, 000 Pieces/Month
Product Images of Tb Tuberculosis Ab Test Cassette Medomics
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Product Description
Medomics Tuberculosis IgG Antibody Test Kit is intended for professional use as an aid in the detection of antibodies against M. tuberculosis in human whole blood. The Rapid TB Test identifies antibodies to TB with a high degree of accuracy.
Specification:
| Product name | Tests | Specimen | Format | Platform | Packaging |
| Tuberculosis IgG Antibody Test Kit | Tuberculosis IgG Antibody Test Kit | Whole Blood | Cassette | GICA | 20pcs/box |
Features:
Specificity: 98%
Sensitivity: 98%
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.
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 Tuberculosis IgG Antibody Test Kit has a specificity of 98% and a sensitivity of 98%.
- What type of specimen is required for testing?
- The test is designed for use with human whole blood specimens.
- Is this test kit for professional or home use?
- It is intended for professional use as an aid in the detection of antibodies against M. tuberculosis.
- What certifications does the product have?
- The product is certified with CE and ISO13485.
- Can I customize the product packaging or design?
- Yes, we offer full customization, minor customization, and flexible customization from samples or designs.
- What is the minimum order quantity (MOQ)?
- 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 payment.
- What is the average lead time for delivery?
- The average lead time is within 15 workdays for both peak and off-season periods.
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