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Sickle Cell Disease Rapid Test Kit (GICA)
Negotiable
3,000 Pieces
Sample price:US$2.50/piece.Request sample
Product profile
Customization
AvailableClassification
IvdType
Rapid Test KitModel NO.
Rapid TestCertification
CE, ISO13485Transport Package
Box+CartonSpecification
401mm*673mm*475mmTrademark
OBM/OEMOrigin
ChinaHS Code
3002150090Production Capacity
5, 000, 000 Pieces/MonthKey features
Rapid Diagnosis Capability: Provides quick qualitative results for HbA, HbS, and HbC variants within 10-15 minutes.
Comprehensive Hemoglobin Detection: Detects Sickle Cell Trait, Disease, and HbC variants with a limit of detection under 1 g/dL.
CE and ISO13485 Certified: Manufactured in GMP workshop meeting FDA, CE, and CFDA standards for quality assurance.
Flexible Customization Options: Offers full, minor, and flexible customization from samples or designs for OEM/ODM needs.
Internal Quality Control: Includes a monoclonal antibody control line to ensure test validity and accuracy.
Minimal Sample Requirement: Requires only 5 microliters of whole blood from fingerstick or venipuncture.
Global R&D Support: Backed by Medomics with over 10,000 sqm GMP facility and 42 R&D engineers.
Company profile
CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Customization from Samples, Customization from Designs, etc. CertifiedExport Year: 7 Years CertifiedNearest Port: Shanghai PortAverage Response Time: ≤9.69h
AI-Powered supplier vetting
SummaryJiangsu Medomics Medical Technology Co., Ltd. is an innovative high-tech enterprise based in Nanjing, China, focusing on medical devices R&D, production, and sales. The company holds ISO 13485 and CE certifications, demonstrating a strong commitment to quality assurance. It provides extensive R&D capabilities, including ODM services, and offers various customization options. Despite lacking overseas warehouse and showroom capabilities, it effectively manages in-stock services and participates in international trade shows. Financial credibility appears stable with reported data over the last three years, but lacks detailed analysis.
Supplier typeJiangsu Medomics Medical Technology Co., Ltd. is a high-tech enterprise specializing in the production and sales of medical devices and biological reagents.
CertificationsThe company holds ISO 13485 Quality system and European CE Certification, indicating compliance with international standards.
After-Sales capabilityThe supplier has clear procedures and records for corrective actions and handling customer complaints, ensuring effective after-sales service.
R&D capabilityThe supplier shows strong innovation capability with 42 R&D engineers, ongoing product development, and ODM service provision.
Customization capabilityThe company offers a wide range of customization services, including full and minor customization options.
Client casesThe supplier is on an updated list of approved suppliers with service capability, indicating customer trust and approval.
Product Q&A
Q:What is the intended use of this test kit?
A:
It is a lateral flow chromatographic qualitative immunoassay to aid in the rapid diagnosis of sickle cell disorders of hemoglobins A, S, and C using fingerstick or venipuncture whole blood samples.
Q:How long does it take to get results?
A:
Results should be read within 10 to 15 minutes after applying the specimen. Results read after 15 minutes may give erroneous results.
Q:What samples can be used for testing?
A:
The kit uses human capillary fingerstick or whole blood samples. It requires only 5 microliters of blood.
Q:Are there any patients who should not be tested?
A:
Do not test patients who have received a blood transfusion in the preceding 6 months. Performance has not been established for sickle cell patients with beta-thalassemia.
Q:What certifications does the product have?
A:
The product holds CE and ISO13485 certifications and is manufactured in a GMP workshop meeting FDA standards.
Send Inquiry
*To:
Jiangsu Medomics Medical Technology Co., Ltd.
Jiangsu Medomics Medical Technology Co., Ltd.*Content:
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