What is the minimum order quantity?

The minimum order quantity is 10 PCS.

What is the lead time for production?

Peak season lead time is one month, while off-season lead time is within 15 workdays.

Disease 19 Diagnostic Rapid Test, AG Test with CE /White List

Name: Disease 19 Diagnostic Rapid Test, AG Test with CE /White List
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 790504662

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$1.50-2.50

1,200 Pieces

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Certification

CE, ISO13485, White List

Classification

Ivd

Type

Rapid Test Kit

Group

All

Certificate

CE, ISO

Material

Plastic

Application

Disease Test

Specimens

Nose Sampling

Quality Guarantee Period

Two Years

Feature 1

Fast Results in 2-15 Minutes

Feature 2

High Sensitivity and Specificity

Feature 3

Factory Price

Sensitivity

95.87%-99.51%

Specificity

97.18%-99.67%

Accuracy

97.5%-99.47%

Transport Package

Box/Carton

Specification

20pcs/box, 1pc/box

Trademark

Singclean

Origin

China

Production Capacity

50000PCS/Day

Key features

High Diagnostic Accuracy: Sensitivity 95.87%-99.51%, Specificity 97.18%-99.67%, Accuracy 97.5%-99.47%.

Rapid Result Delivery: Obtain qualitative IgG/IgM antibody results in just 2-15 minutes.

Multi-Sample Compatibility: Supports detection in human whole blood, serum, or plasma samples.

Flexible Customization: Full customization options available for OEM and ODM services.

Global Certifications: CE, ISO13485, and White List certified for international compliance.

Comprehensive Kit Contents: Includes test kits, swabs, extraction tubes, buffer, and instructions.

Quality Assurance: Two-year quality guarantee with 100% finished product inspection.

Company profile

Importers and ExportersExhibition Experience

Hangzhou Singclean Medical Products Co., Ltd.

Zhejiang, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service Available CertifiedCustomization Options: Full Customization CertifiedExport Year: Shanghai Port CertifiedNearest Port: Shanghai PortAverage Response Time: ≤5.10h

AI-Powered supplier vetting

SummaryThe supplier is identified as a manufacturing factory in Hangzhou’s Qiantang District, with a business scope covering medical devices, cosmetics, masks, disinfectants, technical services, and import/export activities. It reports ISO 9001:2015 and CE certifications, 100% finished-product inspection, 58 quality assurance and control inspectors, and documented corrective-action and complaint-handling procedures. Manufacturing contracts with associated subcontractors are in place, and the supplier offers OEM, ODM, and broad customization services. However, it reports no in-stock capacity, overseas warehouse, overseas showroom, overseas agents or branches, or SDK availability. No new product was developed in the past year, and the company did not conduct regular fire drills during that period. Customer-case evidence is limited to OEM service for well-known brands and participation in one offline trade event.

Supplier typeThe supplier is explicitly identified as a factory, with associated companies in manufacturing. Its registered business scope includes first-category medical device production, second-category medical device sales, cosmetics, masks, disinfectants, technical services, and import/export activities.

CertificationsThe supplier reports an ISO 9001:2015 management-system certificate and CE certification for products. It also states that quality assurance exists and that quality-control processes are supported by documented procedures and records.

R&D capabilityThe supplier reports no available SDK and no new products during the past year, which are explicit limitations for software-enabled and recent product innovation. It does provide ODM services, but the available evidence does not establish strong ongoing innovation capability.

Production capacityThe supplier is a manufacturing factory with 100% finished-product inspection, 58 quality assurance and control inspectors, listed mixing, filling, sterilizing, and packing equipment, and a reported peak-season fulfillment time of one month. Valid manufacturing contracts with associated subcontractors are in place, although the supplier has no in-stock capacity.

Customization capabilityThe supplier explicitly offers customization from samples, customization from designs, and full customization. It also provides ODM services and reports OEM capability for well-known brands, while its own-brand product quality-control capability covers Singclean and Singjoint.