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All the rapid test kits are developed and manufactured strictly under FDA, CE, ISO and GMP criteria.

CE Approved One Step Dengue Igg Igm Antibody Rapid Test Kit

Name: CE Approved One Step Dengue Igg Igm Antibody Rapid Test Kit
Brand: Safecare Biotech(Hangzhou) Co., Ltd.
SKU: 2296517005

Zhejiang, ChinaSafecare Biotech(Hangzhou) Co., Ltd.

US$0.45

1,000-4,999 Pieces

US$0.43

5,000-9,999 Pieces

US$0.40

10,000+ Pieces

Sample price:US$0.10/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Brand

Safecare/OEM

Model NO.

4022

Product Model

4022

Material

Plastic

Shelf Life

2 Years

Quality Certification

Sample

Urine

Safety Standards

ISO13485

Classification of Medical Devices

Class 2

Applicable Area

Health Care /Professional Testing/Rapid Test

Transport Package

Carton

Trademark

Safecare/OEM

Origin

Zhejiang, China

Production Capacity

5000000 Pieces Per Month

Key features

Rapid 15-Minute Results: Provides speedy and accurate detection of Dengue IgG and IgM antibodies in just 15 minutes.

High Clinical Accuracy: IgM sensitivity 96.9%, specificity 98.9%; IgG sensitivity 94.1%, specificity 99.3%.

Multi-Sample Compatibility: Suitable for qualitative detection in whole blood, serum, and plasma specimens.

Easy One-Step Operation: Designed for expert use with clear visible results requiring no extra laboratory equipment.

Comprehensive OEM/ODM Services: Offers customized branding, packaging, multi-language artwork, and local registration support.

International Quality Certifications: Manufactured under FDA, CE, ISO13485, and GMP criteria for global compliance.

Low Minimum Order Quantity: Accepts small quantity orders starting from 1000 pieces for evaluation.

2-Year Shelf Life: Ensures product stability and reliability for up to 24 months from manufacture.

Company profile

Importers and ExportersHigh Repeat Buyers ChoiceYears of Export ExperienceExperienced Team

Safecare Biotech(Hangzhou) Co., Ltd.

Zhejiang, 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.Export Year: 2012-05-01Nearest Port: Shanghai, Nningbo, QingdaoAverage Response Time: ≤6.07h

About Our Factory & Business Background

Address4th Floor, Block A, Building 1, Huamao Science and Innovation Park, No. 2628 Yuhangtang Road, Yuhang District, Hangzhou City, Zhejiang Province

Plant Area31517 square meters

Number of Employees185

Registered Capital6,100,000 RMB

Terms of PaymentLC, T/T, D/P, PayPal

International Commercial Terms(Incoterms)FOB, EXW, CFR, CIF, DDP, FCA

Average Lead TimePeak Season Lead Time: within 15 workdays Off Season Lead Time: within 15 workdays

Supply Chain Partners8

Our Production Capability & Technical Expertise

Main ProductsDrug Test, HCG Test, Infectious Disease Tests, Cardiac Markers Tests, Biochemistry Tests

Production MachinesPurified Water Equipment, Automatic Card Pressing and Bagging Machine, Automatic Labeling Machine

Inspection Method for Finished ProductsFinished product checked by packing staff

Traceability of Raw MaterialsYes

Our Industry Experience & Global Business Record

Year of Establishment2012-11-07

Main MarketsNorth America, South America, Eastern Europe, Southeast Asia, Eastern Asia, Mid East, Africa, Oceania

Repeat Buyers Choice80%~100%

Product Q&A

Q:Can we get samples before bulk order?

Yes, sample orders are available for evaluation. We support distributors and medical partners to test product performance before placing bulk orders.

Q:Do you support OEM / ODM services?

Yes. Safecare is a professional OEM/ODM manufacturer with strong customization capabilities. We provide private label packaging, custom logo, kit configuration customization, and product design support for distributors and brand owners.

Q:What products can I buy?

We focus on Drug of Abuse Tests, Infectious Disease Tests, Women's Health Tests, Cardiac Marker Tests, and Tumor Marker Tests.

Q:What services can we provide?

Accepted Delivery Terms: FOB, CFR, CIF, EXW, CIP, DDP, DDU, Express Delivery; Accepted Payment Currency: USD, EUR, CNY; Accepted Payment Type: T/T, L/C, PayPal, Western Union, Escrow; Language Spoken: English, Chinese, Spanish.

Q:What is the MOQ?

Small quantity like 1000pcs is available.