What is the daily production capacity?

The daily production capacity is 1,500,000 units.

What are the storage conditions?

The product should be stored at temperatures between 4 and 30 degrees Celsius.

What is the instrument classification?

This product is classified as a Class III instrument.

Testsealabs Factory CE ISO Certificate Dengue Rapid Test Kits

Name: Testsealabs Factory CE ISO Certificate Dengue Rapid Test Kits
Brand: HangZhou Testsea biotechnology Co., Ltd.
SKU: 1916781131

Zhejiang, ChinaHangZhou Testsea biotechnology Co., Ltd.

US$1.30

1,000-9,999 Pieces

US$1.10

10,000-99,999 Pieces

US$0.60

100,000+ Pieces

Sample price:US$0.01/piece.Request sample

Product profile

Customization

Available

Model

101010

Accuracy

More Than 98%

Quality Certification

CE; ISO 13485; MSDS

OEM

Available

Shelf Life

24 Months

Instrument Classification

Class III

Transport Package

Carton

Trademark

TESTSEALABS

Origin

China

HS Code

382219

Production Capacity

3000000000 Tests/ Year

Key features

High Accuracy Rate: Accuracy is more than 98% for reliable diagnostic results.

Multiple Certifications: Holds CE, ISO 13485, and MSDS certifications for global compliance.

OEM Service Available: Customization services including OEM are available for this product.

Fast Testing Time: Results are available within 15 minutes for efficient diagnosis.

High Production Capacity: Daily production capacity reaches 1,500,000 units.

Long Shelf Life: Product remains valid for 24 months when stored correctly.

Class III Instrument: Categorized as Class III medical device for professional use.

GMP Workshop: Manufactured in a 100,000-level GMP purification workshop.

Company profile

HangZhou Testsea biotechnology Co., Ltd.

Zhejiang, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service Available & OEM Service AvailableExport Year: 2022-04-08Nearest Port: Shanghai, Ningbo, ShenzhenAverage Response Time: ≤10.15h CertifiedTerms of Payment: LC, T/T, D/P

AI-Powered supplier vetting

SummaryTestsea Biotechnology is identified as a China-based limited company in Hangzhou, with records describing it as both a trading company and manufacturer/factory. Its stated capabilities include in-vitro diagnostic, veterinary, rapid-test, reagent, and medical-machine products. The supplier reports ISO 9001 and GMP certification, more than 10 production lines, 50 R&D engineers, 50 quality-control staff, and exports to multiple global regions. It describes three technical platforms and sales coverage exceeding 100 countries and regions. However, the evidence does not establish after-sales performance, financial credibility, or product-customization capability. One record associates the supplier with a 2025 THC urine-test product and a Vietnamese buyer, but this is limited customer evidence and does not independently verify broader performance.

Supplier typeThe supplier is identified as a limited company headquartered in Hangzhou, China, and is described as both a trading company/manufacturer-factory. A separate record characterizes the company nature as a factory, supporting a manufacturing role alongside trading activity.

CertificationsThe supplier reports ISO 9001 and GMP certification under its management-system certifications. These are explicit certifications relevant to quality and manufacturing controls.

R&D capabilityThe supplier states that it develops core innovative raw-material technologies and has established immunological detection, molecular-biology detection, and protein core-sheet inspection platforms. The reported 50 R&D engineers and continuing R&D investment further support an established innovation function.

Production capacityThe supplier reports more than 10 production lines, 50 quality-control staff, a one-month off-peak lead time, and broad diagnostic-product offerings. It also reports 90% export sales and access to Shanghai, Ningbo, and Shenzhen ports, although the stated peak-season fulfillment time of 6–12 months indicates substantial seasonal capacity constraints.

Client casesThe supplier states that its products have been sold in more than 100 countries and regions. A separate record identifies a THC urine-test product and one associated Vietnamese buyer, but it does not provide verifiable case details such as order scale, duration, performance results, or references.