What certifications does the product have?

The product is certified with CE and ISO13485.

What is the sensitivity of the test?

The test has a sensitivity of 20ng/ml.

What is the normal range for urine albumin?

The normal UACR value is less than or equal to 30 mg/g, with specific thresholds varying by gender.

Kidney Funtion Self Test Ivd Diagnostic Test

Name: Kidney Funtion Self Test Ivd Diagnostic Test
Brand: Henan Season Medical Device Co., Ltd.
SKU: 1916501526

Henan, ChinaHenan Season Medical Device Co., Ltd.

US$1.80

10,000-49,999 Pieces

US$1.60

50,000-99,999 Pieces

US$1.40

100,000+ Pieces

Sample price:US$0.10/piece.Request sample

Product profile

Customization

Available

Type

IVD Reagent

Classification

Biological Diagnostics

Model NO.

SU-003

Certification

CE, ISO13485

Group

All Groups

Accuracy

98%

Specimen

Urine

Format

Midstream or Strip

Product

Mau Rapid Test

Quality Certification

CE, ISO13485

Sensitivity

20ng/Ml

Validity

24 Months

Wide Linear Range

20-300ng/Ml

Transport Package

Carton

Specification

Cassette

Trademark

Origin

Zhejiang

HS Code

3822190090

Production Capacity

300000PCS/Day

Key features

High Accuracy Rate: Achieves 98% accuracy in detecting microalbuminuria for early diagnosis.

Fast Result Time: Read results within 5 minutes for quick decision-making.

CE and ISO13485 Certified: Meets international safety and quality standards for medical devices.

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

OEM Service Available: Custom branding available with a lead time of 20 days.

Multiple Format Options: Available in Midstream or Strip formats for versatile usage.

High Sensitivity: Detects albumin levels as low as 20ng/ml with precision.

Wide Linear Range: Effective detection range from 20 to 300ng/ml for accurate results.

Company profile

Henan Season Medical Device Co., Ltd.

Henan, China

Business Type: Manufacturer/FactoryExport Year: 2005-08-05Nearest Port: Shanghai, TIANJINAverage Response Time: ≤4.00hTerms of Payment: T/T, PayPal, Western Union, etc.International Commercial Terms(Incoterms): FOB, EXW, CFR, CIF, DDP, DAP, FCA

AI-Powered supplier vetting

SummaryHenan Season Medical Device Co., Ltd. is identified as a Chinese manufacturer/factory specializing in point-of-care and in-vitro diagnostic self-testing products. The supplier reports eight production lines, annual Early Pregnancy HCG test output of 10,000,000 pieces, and lead times of within 15 working days in both peak and off-peak seasons. Its stated export coverage is broad, with exports accounting for 90% of total sales. ISO 9001, ISO 13485, ISO 14001, and CE/FDA-related approvals are reported. Evidence also indicates OEM packaging, R&D engineers, and quality-control staff. However, the provided information does not sufficiently establish after-sales service processes, financial credibility, or verified customer case depth. Trade data shows only one transaction, which is insufficient to demonstrate an established customer track record.

Supplier typeThe supplier is explicitly identified as a Manufacturer/Factory and Limited Company based in Zhengzhou, Henan, China. Its stated business focuses on biomedical IVD and rapid self-testing products, indicating direct manufacturing involvement rather than only trading activity.

CertificationsThe supplier reports ISO 9001, ISO 13485, and ISO 14001 certifications or approvals, and states that its products have received CE approval in Europe and FDA approval in the United States. These claims provide explicit evidence of a certification and regulatory-compliance capability, although the slices do not provide certificate numbers, validity dates, or scope details.

R&D capabilityThe supplier reports 6–10 years of R&D engineer experience and offers a broad range of rapid and self-testing products, including digital pregnancy and ovulation tests, vitamin D, UTI, syphilis, and drug tests. This supports product-development capability, although no specific patents, new-product launches, or measurable innovation outcomes are provided.

Production capacityThe supplier reports eight production lines, annual Early Pregnancy HCG test output of 10,000,000 pieces, and order fulfillment within 15 working days during both peak and off-peak seasons. Its export sales share is reported as 90%, indicating stated production and international fulfillment experience.

Customization capabilityThe supplier explicitly offers OEM packaging and states that it provides customer-specific solutions and configurations. This supports packaging-level customization, but the slices do not confirm broader customization such as formulation, tooling, labeling compliance, or product design changes.