What are the main features to compare with other suppliers?

Compare accuracy, sensitivity, specificity, and price to determine the best value.

What is the lead time for orders?

Lead time is 3-5 business days after payment confirmation, depending on quantity. Peak and off-season lead times are within 15 workdays.

Factory Direct HCG Test Kit for Accurate Urine Early Pregnancy Screening

Name: Factory Direct HCG Test Kit for Accurate Urine Early Pregnancy Screening
Brand: Shandong Highplus Biotech Co., Ltd.
SKU: 2182169072

Shandong, ChinaShandong Highplus Biotech Co., Ltd.

US$0.20

1,000-999,999 Pieces

US$0.01

1,000,000+ Pieces

Product specifications

CM

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Classification

Biological Diagnostics

Type

Urine Analyzer

Model NO.

HCG

Certification

CE, FDA, ISO13485

Group

Middle-aged and Old

Specimen

Urine / Serum

Methodology

Colloidal Gold Immune Chromatographic Assay

Storage

4-30℃

OEM

Acceptable

ODM

Acceptable

Sample

Acceptable

Advantage

Fast and Easy to Use

Result

5 Minutes

MOQ

1000

Lead Time

30 Days

Affordable Price

0.2-0.01

Transport Package

Individual Foil Pouch/ Customized Package

Specification

Customized Package

Trademark

OEM

Origin

China

HS Code

3002190090

Production Capacity

200000PCS/Week

Key features

High Accuracy Rate: Over 99% accuracy for reliable early pregnancy screening results.

Rapid Result Reading: Obtain clear results within 5 minutes of testing.

Multiple Formats Available: Choose from strip, cassette, or midstream formats to suit your needs.

Flexible Customization: OEM and ODM services are acceptable for branding and packaging.

Certified Quality: Products hold CE, FDA, and ISO13485 certifications for safety.

Long Shelf Life: Ensures product stability and usability for up to 3 years.

Versatile Specimen Types: Supports testing with both urine and serum specimens.

Affordable Pricing: Competitive factory direct pricing ranging from $0.01 to $0.20.

Company profile

Shandong Highplus Biotech Co., Ltd.

Shandong, China

CertifiedBusiness Type: Trading CompanyExport Year: 2018-05-30 CertifiedNearest Port: Qingdao PortAverage Response Time: ≤2.04h CertifiedTerms of Payment: T/T, D/P, PayPal, etc. CertifiedInternational Commercial Terms(Incoterms): FOB, CIF, CFR

AI-Powered supplier vetting

SummaryShandong Highplus Biotech Co., Ltd. is a China-based limited company in Weifang, Shandong, identified as both a trading company and manufacturer/factory focused on in vitro diagnostic reagents and POCT-related products. It reports ISO 13485 and ISO 9001 management-system certifications and states that most products have CE, CFDA, FDA, and Free Sale Certificates, although product-specific verification is not provided. The supplier reports more than 10 production lines, 11–20 years of R&D engineer experience, 6–10 quality-control staff, export sales accounting for 90% of total sales, and markets spanning multiple regions. Delivery is stated as within 15 workdays in both peak and off-peak periods. The evidence does not establish after-sales service capability, customization capability, or customer cases. Financial information is not assessed because monetary figures are excluded.

Supplier typeThe supplier is explicitly classified as both a trading company and manufacturer/factory. Its stated business focuses on in vitro diagnostic reagents, POCT analyzer-related products, rapid test kits, test strips, analysis equipment, and related materials, with a factory location identified in Weifang, Shandong.

CertificationsThe supplier explicitly reports ISO 13485 and ISO 9001 certifications for its management systems. It also states that most products have CE, CFDA, FDA, and Free Sale Certificates, but the supplied information does not identify certificate numbers, validity periods, or product-specific coverage.

R&D capabilityThe supplier states that it develops or supplies in vitro diagnostic reagents, POCT analyzer-related products, chemiluminescent immunoassay reagents, and bioactive materials. It reports 11–20 years of R&D engineer experience, which supports an established technical resource base, but no evidence is provided on patents, new-product launches, dedicated R&D investment, or proprietary technologies.

Production capacityThe supplier reports more than 10 production lines, 6–10 quality-control staff, and order fulfillment within 15 workdays during both peak and off-peak seasons. It also exports to multiple global regions and identifies factory premises in Weifang, indicating established manufacturing and international fulfillment capacity.

Product Q&A

Q:What testing method is used?

The test utilizes the Colloidal Gold Immune Chromatographic Assay method.

Q:What is the MOQ for different formats?

For strip format, the MOQ is 5000pcs. For cassette and midstream formats, the MOQ is 2000pcs.

Q:What are the packing options?

Options include bulk packing (pouches in bags/cartons) for cost savings or boxed packaging for retail and strict regulatory requirements.

Q:What is the difference between serum/plasma and whole blood tests?

Whole blood tests require additional accessories like buffer and lancets for home use. Serum/plasma tests require centrifugation, are better for labs/hospitals, and generally provide more accurate results.

Q:How can I distinguish a good test kit?

Evaluate technical data (accuracy, specificity, sensitivity), pouch sealing tightness, flow speed, and background cleanliness after running.