What are the lead times for samples and OEM?

Sample lead time is within 15 days, and OEM lead time is within 25 days.

What certificates does the product have?

The product is CE, ISO, and FSC certified.

CE Approved Anti-HCV Rapid Test Kit for Hepatitis C Infection Diagnosis

Name: CE Approved Anti-HCV Rapid Test Kit for Hepatitis C Infection Diagnosis
Brand: Shandong Highplus Biotech Co., Ltd.
SKU: 2139646752

Shandong, ChinaShandong Highplus Biotech Co., Ltd.

US$0.20

1,000-9,999,999 Pieces

US$0.01

10,000,000+ Pieces

Product specifications

CM

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Material

Plastic

Model NO.

HCV-W11

Cheap Price

0.01--0.2

Sensitivity

High

MOQ

1000

Read Time

Within 10 Minutes

Brand Name

OEM

Acceptable

ODM

Acceptable

Sample

Acceptable

Advantage

Fast and Easy to Use

Transport Package

PP, Carton

Specification

Strip/Cassette

Trademark

OEM

Origin

China

HS Code

300219009

Production Capacity

500000PCS/Month

Key features

High Accuracy Rate: Over 99.5% accuracy for reliable Hepatitis C diagnosis.

Fast Result Time: Results available within 10-20 minutes for quick assessment.

Multiple Specimen Types: Supports whole blood, serum, and plasma testing.

CE and ISO Certified: Complies with CE, ISO, and FSC standards for safety.

OEM and ODM Support: Acceptable for custom branding and design services.

Flexible Packaging: Options for bulk pouches or retail boxes for pharmacies.

Colloidal Gold Technology: Advanced method ensuring clear background and sensitivity.

Competitive Pricing: Low cost options available starting from $0.01.

Company profile

Shandong Highplus Biotech Co., Ltd.

Shandong, China

CertifiedBusiness Type: Trading CompanyExport Year: 2018-05-30 CertifiedNearest Port: Qingdao PortAverage Response Time: ≤2.89h 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 Method for detection.

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

The MOQ is 5000 pcs for strip format and 2000 pcs for cassette format.

Q:How is the product packed?

Options include bulk packing (100-40 pouches per bag) or retail boxes (100 pcs/box) for pharmacies.

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

Whole blood tests require buffer and lancets for home use, while serum/plasma tests require centrifugation and are better for labs/hospitals, offering higher accuracy.

Q:How can I distinguish a good test kit?

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