What are the key features to compare with other suppliers?

Compare accuracy, sensitivity, specificity, and price.

Ivd Grade HCG Test Kit for Reliable Human Pregnancy Rapid Diagnosis

Name: Ivd Grade HCG Test Kit for Reliable Human Pregnancy Rapid Diagnosis
Brand: Shandong Highplus Biotech Co., Ltd.
SKU: 2177764622

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 pregnancy diagnosis results.

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

Multiple Formats Available: Options include strips, cassettes, and midstream devices.

Flexible Customization: OEM, ODM, and sample services are fully acceptable.

Certified Quality: CE, FDA, and ISO13485 certified for safety and compliance.

Long Shelf Life: Stable product with a 3-year shelf life for storage.

Versatile Specimen Types: Compatible with both urine and serum specimen collection.

Adjustable Sensitivity: Available in 10miu, 20miu, and 25miu sensitivity levels.

Company profile

Shandong Highplus Biotech Co., Ltd.

Shandong, China

CertifiedBusiness Type: Trading CompanyExport Year: 2018-05-30 CertifiedNearest Port: Qingdao PortAverage Response Time: ≤1.81h 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?

Colloidal Gold 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 (1 test in a pouch, 100/40 pouches in a bag, 50 bags in a carton) or boxed packing (e.g., 100pcs in a box) for strict retail requirements.

Q:How to distinguish a good test kit?

Judge by technical data (accuracy, specificity, sensitivity), tight pouch sealing, appropriate flow speed, and a clean background without red smears.

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

Whole blood tests require buffer, lancet, and alcohol swab for home use. Serum/plasma tests require centrifugation, are better for labs/hospitals, and generally provide more accurate results.