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Yes, the GMP purification production workshop meets the product standards of FDA, CE, and CFDA.

C-O-R-O-N-a Virus Disease Rapid Antibody Detection Test Kit

Name: C-O-R-O-N-a Virus Disease Rapid Antibody Detection Test Kit
Brand: Jiangsu Medomics Medical Technology Co., Ltd.
SKU: 1903084565

Jiangsu, ChinaJiangsu Medomics Medical Technology Co., Ltd.

Negotiable

3,000 Pieces

Sample price:US$2.50/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Transport Package

Box+Carton

Model NO.

antibody test

Trademark

OBM/OEM

Origin

China

HS Code

3002150090

Production Capacity

5, 000, 000 Pieces/Month

Key features

Rapid 15-Min Results: Delivers clear test results in just 15 minutes with no equipment needed.

Multi-Sample Compatibility: Can test whole blood, serums, and plasma using only 4 simple steps.

Dual Antibody Detection: Tests for 2 antibodies simultaneously for comprehensive disease screening.

No Sample Transport: Designed for immediate testing without the need for complex sample transport.

FDA, CE & CFDA Certified: Manufactured in GMP workshops meeting strict FDA, CE, and CFDA standards.

Flexible Customization: Supports full customization, minor customization, and customization from samples or designs.

Low MOQ Requirement: Minimum Order Quantity is just 1 Set, ideal for small-scale testing needs.

Fast Lead Time: Average lead time is within 15 workdays for both peak and off-season periods.

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: ≤15h

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.