What certificate does the product have?

The product has ISO 13485 certification.

P Specimen

Name: Testsealabs Early Screening HAV Hepatitis A Virus Igg/Igm Test Kit WB/S/P Specimen
Brand: HangZhou Testsea biotechnology Co., Ltd.
SKU: 1918282731

Zhejiang, ChinaHangZhou Testsea biotechnology Co., Ltd.

US$0.50-0.70

1,000 Pieces

Sample price:US$0.00/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Product Name

HAV Hepatitis a Virus Igg/Igm Test

Model NO.

101028

Specimen

Serum/Plasma

Format

Cassette

Certificate

ISO 13485

Storage Temperature

4-30°c

Shelf Life

2 Years

OEM&ODM

Available

Transport Package

Cartons

Specification

66*36*56.5cm/2000 Tests/CTN/12.0kg

Trademark

Testsealabs

Origin

Hangzhou, China

Production Capacity

10000pieces/Day

Key features

High Sensitivity: Sensitivity exceeds 92% for accurate detection of HAV antibodies.

Rapid Results: Get visual results in just 15 minutes with this one-step test.

OEM/ODM Support: Custom branding and manufacturing services are available for partners.

Certified Quality: Product holds ISO 13485 certificate ensuring quality standards.

Versatile Specimen: Compatible with both serum and plasma specimens for flexibility.

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: ≤9.55h 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.