What is the warranty period for the product?

The product has a warranty of 24 months at room temperature.

What are the main features to compare with other suppliers?

Compare accuracy, sensitivity, specificity, and price to evaluate the main differences.

High Grade One Step Syphilis Tp Rapid Test Kit Medical Device

Name: High Grade One Step Syphilis Tp Rapid Test Kit Medical Device
Brand: Shandong Highplus Biotech Co., Ltd.
SKU: 2136531522

Shandong, ChinaShandong Highplus Biotech Co., Ltd.

US$0.20

1,000-9,999 Pieces

US$0.10

10,000+ Pieces

Product specifications

CM

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Classification

Biological Diagnostics

Type

Urine Analyzer

Model NO.

Certification

CE, FDA, ISO13485, SGS

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: Accuracy rate exceeds 99% for reliable qualitative detection of Syphilis antibodies.

Multiple Specimen Types: Supports testing with whole blood, serum, or plasma for flexible usage scenarios.

Fast Reading Time: Results can be read within 15 minutes for quick diagnosis and decision making.

Comprehensive Certifications: Certified by CE, FDA, ISO13485, SGS, and FSC ensuring global compliance.

OEM and ODM Support: Acceptable OEM and ODM services to meet specific branding and packaging needs.

Long Shelf Life: Stable for 24 months when stored at room temperature, ensuring product longevity.

Colloidal Gold Technology: Utilizes advanced colloidal gold method for excellent sensitivity and quality.

24-Hour Response Service: Dedicated staff provides solutions and feedback within 24 hours for any issues.

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 method is used for the test?

The test uses the Colloidal Gold Method.

Q:What is the MOQ for different formats?

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

Q:What are the packing options available?

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 stricter requirements.

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, are better for labs/hospitals, and generally provide more accurate results.

Q:How can I distinguish a good test kit?

Judge by technical data (accuracy, specificity, sensitivity), pouch sealing tightness, flow speed, and background cleanliness after running.