Is customization available for this product?

Yes, full customization, minor customization, and flexible customization from samples or designs are available.

What is the minimum order quantity?

The minimum order quantity is 1 Set.

Sickle Cell Disease Rapid Test Kit (GICA)

Name: Sickle Cell Disease Rapid Test Kit (GICA)
Brand: Jiangsu Medomics Medical Technology Co., Ltd.
SKU: 2086492415

Jiangsu, ChinaJiangsu Medomics Medical Technology Co., Ltd.

Negotiable

3,000 Pieces

Sample price:US$2.50/piece.Request sample

Product profile

Customization

Available

Classification

Ivd

Type

Rapid Test Kit

Model NO.

Rapid Test

Certification

CE, ISO13485

Transport Package

Box+Carton

Specification

401mm*673mm*475mm

Trademark

OBM/OEM

Origin

China

HS Code

3002150090

Production Capacity

5, 000, 000 Pieces/Month

Key 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

Importers and ExportersHigh Repeat Buyers ChoiceExperienced TeamExhibition Experience

Jiangsu Medomics Medical Technology Co., Ltd.

Jiangsu, China

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: ≤18h

AI-Powered supplier vetting

SummaryJiangsu Medomics Medical Technology Co., Ltd. is an innovation-oriented medical-device enterprise in Nanjing engaged in the production and sale of biological and laboratory reagents, consumables, instruments, equipment, and medical devices. The supplier demonstrates broad customization and ODM capabilities, recent new-product development, OEM experience for well-known brands, raw-material traceability, and documented corrective-action and complaint-handling procedures. Its products are developed under ISO 13485 and have European CE certification. Service strengths include stocked inventory, stated lead times within 15 workdays in both peak and off-season periods, and participation in Medlab Middle East. Limitations include no valid manufacturing contract with related subcontractors, no overseas warehouse, showroom, agent, or branch, no overseas-service countries reported, and no available SDK. Financial credibility cannot be assessed from the provided information.

Supplier typeThe supplier is identified as a high-tech medical-device enterprise involved in R&D, production, and sales. Its stated business scope also covers biological and laboratory reagents, consumables, instruments, and equipment, subject to required regulatory approvals for applicable projects.

CertificationsThe supplier states that its product series were developed according to the ISO 13485 quality system and have European CE certification. This is explicit evidence of relevant quality-system and product-certification coverage.

After-Sales capabilityDocumented procedures and records exist for corrective and preventive actions and customer complaint handling. The supplier also reports inventory capability and lead times within 15 workdays in both peak and off-season, but has no overseas warehouse, showroom, agent, or branch and reports service coverage in zero countries.

R&D capabilityThe supplier reports new products during the past year, ODM capability, broad design and customization support, and an innovation-driven medical-device R&D profile. It also reports 42 years of total R&D-engineer experience, while no SDK is available; overall evidence supports strong product-development capability, with SDK capability specifically absent.

Production capacityEvidence includes production and sales operations, an automated processing line, raw-material traceability, four quality-assurance and quality-control inspectors, random finished-product inspection, stocked inventory, and stated lead times within 15 workdays. However, the supplier reports no valid manufacturing contract with its related subcontractors, which is a documented production-management weakness.

Customization capabilityThe supplier explicitly supports customization from samples, designs, full customization, minor customization, and flexible customization, and also provides ODM services. These statements directly demonstrate broad customization coverage.

Client casesThe supplier reports OEM service for well-known brands and participation in the Medlab Middle East offline trade show. These indicate some market-facing experience, but no specific customer names, project descriptions, order histories, or verifiable case details are provided.

Product Q&A

Q:What is the intended use of this test kit?

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?

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?

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?

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?

The product holds CE and ISO13485 certifications and is manufactured in a GMP workshop meeting FDA standards.