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Ivd Reagent H. P. Rapid Test Strip/Cassette
US$0.20
1,000-99,999 Pieces
US$0.01
100,000+ Pieces

Product profile

Customization

Available

Classification

Physiological Functions of Diagnosis and Monitoring Equipment

Type

H.P. Test Kit

Model NO.

HP-AG-F23/F11

Certification

CE, FDA, ISO13485

Group

All

Transport Package

Carton

Specification

Strip/Cassette

Trademark

OEM

Origin

China

HS Code

3002190090

Production Capacity

500000000PCS/Year

Key features

CE, FDA, ISO13485 Certified: Product holds CE, FDA, and ISO13485 certifications for quality assurance.
Sandwich Immunochromatographic Assay: Utilizes advanced sandwich solid phase immunochromatographic technology.
High Accuracy Control Line: Red control line confirms correct performance and device functionality.
Clear Visual Results: Distinct red lines indicate positive or negative H. pylori antigen presence.
Multiple Format Options: Available in strips and cassettes for serum, plasma, whole blood, and feces.
Global Market Availability: Exported to North America, Europe, Southeast Asia, Africa, and East Asia.

Company profile

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 is the testing principle of this H. pylori test?
A:
It is a sandwich solid phase immunochromatographic assay using colloidal gold.
Q:What samples can be tested with this product?
A:
It supports stool antigen tests and serum, plasma, or whole blood antibody tests.
Q:How do I interpret the test results?
A:
A red test line indicates positive; only a control line indicates negative; no control line means invalid.
Q:What certifications does the product have?
A:
The product is certified with CE, FDA, and ISO13485 standards.
Q:What are the payment terms?
A:
We accept T/T, D/P, PayPal, Western Union, and small-amount payments.

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