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CE Certified Medical Diagnostic Anti-HCV Rapid Test Kit

Name: CE Certified Medical Diagnostic Anti-HCV Rapid Test Kit
Brand: Shandong Highplus Biotech Co., Ltd.
SKU: 2136253122

Shandong, ChinaShandong Highplus Biotech Co., Ltd.

US$0.20

1,000-99,999 Pieces

US$0.01

100,000+ Pieces

Product specifications

CM

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Classification

Biological Diagnostics

Type

Urine Analyzer

Model NO.

HCV-W11/ HCV-W23

Certification

CE, FDA, ISO13485

Group

Middle-aged and Old

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/ Customized Package

Specification

Customized Package

Trademark

OEM

Origin

China

HS Code

3002190090

Production Capacity

200000PCS/Week

Key features

High Accuracy Rate: Over 99.5% accuracy for reliable diagnostic results.

Fast Read Time: Results available within 10 minutes for quick assessment.

Multiple Certifications: CE, FDA, ISO13485, and TUV certified for global compliance.

Flexible OEM/ODM: Acceptable OEM and ODM services with custom pricing options.

Versatile Specimen Types: Supports whole blood, serum, and plasma for diverse testing needs.

Colloidal Gold Technology: Utilizes advanced colloidal gold method for precise detection.

Easy Home Use Option: Whole blood tests allow easy home use with simple accessories.

Competitive Pricing: Low cost options available with bulk packing suggestions.

Company profile

Shandong Highplus Biotech Co., Ltd.

Shandong, China

CertifiedBusiness Type: Trading CompanyExport Year: 2018-05-30 CertifiedNearest Port: Qingdao PortAverage Response Time: ≤1.96h 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 strip and cassette formats?

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

Q:What are the packing options?

Low cost bulk packing: 1 test in a single pouch, 100/40 pouches in a plastic bag, 50 bags in a carton. For pharmacies or strict requirements: 100pcs in a box or 1 test in a single box.

Q:How to distinguish a good test kit?

Judge by 4 facts: Technical data (accuracy, specificity, sensitivity), Pouch sealing (tight to prevent humidity damage), Flow speed (not too short, allow sufficient reaction time), and Background (clean background without red smears).

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

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