What is the warranty period?

The product has a shelf life of 24 months when stored at room temperature.

What certifications does the product have?

The product is certified by CE, FDA, ISO13485, SGS, TUV, and CFDA.

Precision One Step Medical Device Rapid Syphilis Tp Test Kit

Name: Precision One Step Medical Device Rapid Syphilis Tp Test Kit
Brand: Shandong Highplus Biotech Co., Ltd.
SKU: 2136498882

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 diagnosis of Syphilis antibodies.

Multiple Specimen Types: Detects IgG and IgM antibodies in whole blood, serum, or plasma.

Fast Reading Time: Results can be read within 10 to 15 minutes for quick diagnosis.

Comprehensive Certifications: Certified by CE, FDA, ISO13485, SGS, TUV, and CFDA for quality assurance.

OEM/ODM Support: Acceptable OEM and ODM services for customized branding and packaging.

Colloidal Gold Method: Utilizes advanced colloidal gold technology for high sensitivity and specificity.

24-Hour Response Service: Dedicated staff provides solutions to product issues within 24 hours.

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 for qualitative detection of antibodies.

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?

Options include bulk packing (1 test per pouch) or boxed packing (e.g., 100pcs per box) for retail.

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 to distinguish a good test kit?

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