What are the cutoff levels for Urine?

Urine cutoff levels are 200, 300, or 600ng/Ml.

What certifications does the product have?

It holds CE, ISO 13485, and ISO 9001 certifications.

What is the box specification?

Options include 40 Tests/Box or 50 Strip/Box.

Urine or Saliva Cot Cotinine Rapid Test with CE Approval

Name: Urine or Saliva Cot Cotinine Rapid Test with CE Approval
Brand: HangZhou Testsea biotechnology Co., Ltd.
SKU: 2002240575

Zhejiang, ChinaHangZhou Testsea biotechnology Co., Ltd.

US$0.25

2,000-19,999 Pieces

US$0.20

20,000-99,999 Pieces

US$0.19

100,000+ Pieces

Sample price:US$1.00/piece.Request sample

Product profile

Customization

Available

Type

Rapid Diagnostic Test

Format

Cassette or Strip

Model NO.

108514

Specimen

Urine, Saliva

Box Specification

40 Tests/Box, 50 Strip/Box

Certificate

CE & ISO 13485 & ISO 9001

Urine Cutoff

200/300/600ng/Ml

Saliva Cutoff

30/50ng/Ml

Quantity Per Carton

1000 Tests

Weight/Carton

20.00kg

Shelf Life

24 Months

Test Time

3-5 Minutes

Instrument Classification

Class III

Quality Certification

Transport Package

66*36*56.5cm

Specification

268*124*65mm

Trademark

Testsealabs

Origin

China

HS Code

3822190090

Production Capacity

3 000 000 Tests/Day

Key features

CE & ISO Certifications: Certified with CE, ISO 13485, and ISO 9001 for medical quality standards.

Fast Test Results: Delivers results in just 3-5 minutes for rapid diagnosis.

Dual Specimen Options: Compatible with both Urine and Saliva samples for flexible testing.

Multiple Cutoff Levels: Urine cutoffs at 200/300/600ng/Ml; Saliva at 30/50ng/Ml.

Long Shelf Life: Valid for 24 months ensuring product reliability.

Customizable Format: Available in Cassette or Strip formats to meet specific needs.

Class III Instrument: Classified as Class III medical instrument for professional use.

OEM/ODM Services: Full OEM and ODM services available for custom branding.

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: ≤11.16h 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.