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Reliable Home Use Rapid HIV1+2 Screening Test Kit CE Approved

Name: Reliable Home Use Rapid HIV1+2 Screening Test Kit CE Approved
Brand: Shandong Highplus Biotech Co., Ltd.
SKU: 2140130792

Shandong, ChinaShandong Highplus Biotech Co., Ltd.

US$0.20

10,000-999,999 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

HIV Rapid Test

Model NO.

HIV-W11/W23/W23H

Certification

CE, FDA, ISO13485

Group

All

Cheap Price

0.01--0.2

Cutoff

100%

ISO

TUV Certified

CE

TUV Certified

FDA

510K

MOQ

1000

Sensitivity

High

Read Time

Within 10 Minutes

Brand Name

Highplus

OEM

Acceptable

ODM

Acceptable

Sample

Acceptable

Advantage

Fast and Easy to Use

Storage

4-30℃

Power Source

Electric

Transport Package

Individual Foil Pouch

Specification

Cassette

Trademark

OEM

Origin

China

HS Code

3002190090

Production Capacity

500000000PCS/Year

Key features

CE, FDA, ISO13485 Certified: Product holds CE, FDA 510K, and ISO13485 certifications for quality assurance.

High Sensitivity & Accuracy: Employs sandwich dye conjugate immunoassay for excellent sensitivity and specific results.

Fast Results: Provides clear results within 10 minutes using colloidal gold method.

Multiple Sample Types: Compatible with serum, plasma, and whole blood for versatile testing options.

OEM/ODM Acceptable: Customization services including OEM and ODM are available for bulk orders.

24-Hour Response Service: Dedicated staff ensures prompt feedback within 24 hours for any product issues.

Flexible Packaging Options: Offers bulk packing for cost-efficiency or boxed packaging for retail/pharmacy needs.

Wide Product Range: Supplier offers diverse rapid diagnostic tests including HCG, HIV, Hepatitis, and more.

Company profile

Shandong Highplus Biotech Co., Ltd.

Shandong, China

CertifiedBusiness Type: Trading CompanyExport Year: 2018-05-30 CertifiedNearest Port: Qingdao PortAverage Response Time: ≤1.90h 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 uses the Colloidal Gold Method.

Q:What is the Minimum Order Quantity (MOQ)?

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

Q:What are the packaging options?

Options include bulk packing (1 test in pouch, 100/40 pouches in a bag, 50 bags in a carton) for cost savings, or boxed packaging (100pcs/box or 1 test/box) for retail and strict regulatory requirements.

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

Whole blood tests require buffer, lancet, and alcohol swabs, making them suitable 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 (not necessarily shorter is better), and background cleanliness (no red smears indicating false positives).