What is the shelf life of the test kit?

The period of validity is 36 months.

Is this test suitable for home use?

Yes, the One-Step hCG Pregnancy Test is suitable for both professional and home use.

Rapid Diagnostic Test Kit HCG Pregnancy Cassette Test

Name: Rapid Diagnostic Test Kit HCG Pregnancy Cassette Test
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 623091144

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$0.05-0.27

1,000 Pieces

Sample price:US$0.01/piece.Request sample

Product profile

Customization

Available

Use

Home or Hospital Use

Types

Strips/Midstream/Cassette

Model NO.

FT-H11/12/21/24/31

Packing

Box

Shipment

by Air or by Sea

Type

Test Strips & Test Tube

Group

Adult

Material

Colloidal Gold

Quality Guarantee Period

3 Years

Logo Printing

Singclean or Customized Brand

Transport Package

Carton or Customized Package

Specification

2.5/3/4 mm for strip, 3 & 4 mm for cassette

Trademark

Singclean or Customized brand

Origin

China

HS Code

3822001000

Production Capacity

10000/Day

Key features

High Accuracy Result: Provides over 99% accuracy with qualitative results in just 3 minutes.

High Sensitivity: Detects HCG levels as low as 10-25mIU/ml for early pregnancy detection.

Flexible Formats: Available in Strip, Cassette, and Midstream formats to suit various needs.

OEM & ODM Service: Supports private labeling, custom packaging, and customized assembly.

Certified Quality: Holds CE 0123 and ISO 13485 certificates ensuring medical grade quality.

Long Shelf Life: Valid for 36 months when stored in a cool, dark, and dry place.

Versatile Application: Suitable for both professional clinical use and home self-testing.

Customizable Sensitivity: Sensitivity can be customized, e.g., 10 mIU/ml or 20 mIU/ml.

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: ≤4.96h

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.