Is this test for professional use only?

Yes, this is an In Vitro diagnostic test intended for professional use only. It must not be used after the expiration date.

Singclean Igg/Igm Rapid Diagnosis Test Kit Antibody Test with CE

Name: Singclean Igg/Igm Rapid Diagnosis Test Kit Antibody Test with CE
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 923394445

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$2.50-4.50

500 Pieces

Product profile

Customization

Available

Type

Test Strips & Test Tube

Material

Plastic

Model NO.

Cassette

Quality Guarante

2 Years

Group

All

Use

Detection of Igg and Igm Antibodies

Specimens

Human Wholeblood, Serum or Plasma

Packing

Box and Carton

Shipment

by Air or by Sea

Feature 1

Fast Results in 10-15 Minutes

Feature 2

One Step Disinfection Tablets and Lancets

Feature 3

High Sensitivity and Specificity

Transport Package

Carton or Customized Package

Specification

1 test/box; 20 test/box; 50 test/box

Trademark

Singclean or Customized brand

Origin

China

HS Code

3002150050

Production Capacity

100000PCS/Day

Key features

Rapid 10-15 Min Results: Provides fast qualitative detection of IgG and IgM antibodies in just 10-15 minutes.

High Sensitivity & Specificity: Ensures accurate differential detection of antibodies with high clinical reliability.

Complete Kit with Accessories: Includes test cassettes, droppers, desiccants, alcohol pads, and lancets for immediate use.

No Equipment Needed: Simple one-step procedure with all necessary reagents provided; no centrifuge required for whole blood.

Full Customization Available: Supports OEM/ODM services with full customization options for packaging and branding.

CE Certified Quality: Manufactured under ISO9001:2015 with 100% finished product inspection for safety.

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: ≤5.01h

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.