What is the sensitivity of the test?

The test detects FSH at a concentration of 25mU/mL or greater.

Is the product suitable for users who are already pregnant or in menopause?

No, if you are pregnant or have already entered menopause (no menstrual cycle for 12 consecutive months), this test cannot work properly.

Singclean High Accuracy One Step Lab Homely Fsh Test Kit for Irregular Menstrual Periods

Name: Singclean High Accuracy One Step Lab Homely Fsh Test Kit for Irregular Menstrual Periods
Brand: Hangzhou Singclean Medical Products Co., Ltd.
SKU: 2046858145

Zhejiang, ChinaHangzhou Singclean Medical Products Co., Ltd.

US$0.15-0.51

1,000 Pieces

Product profile

Customization

Available

Type

IVD Reagent

Application

Rapid Test Kit, Rapid Diagnostic Test

Format

Strip, Casstte, Midstream

Accuracy

99%

Certificate

Transport Package

Carton

Specification

2.5/3.0/3.5/4.0/5.5/6.0 mm

Trademark

Singclean or Customized brand

Origin

China

HS Code

3822001000

Production Capacity

10000/Day

Key features

High Accuracy Rate: Delivers 99% accuracy for reliable qualitative determination of FSH levels.

CE Certified Quality: Manufactured with CE certification ensuring compliance with medical standards.

Multiple Format Options: Available in Strip, Cassette, and Midstream formats for diverse user preferences.

Ethylene Oxide Free: Produced without Ethylene Oxide sterilization for safer and cleaner results.

Clear Result Interpretation: Simple visual reading with distinct positive, negative, and invalid indicators.

Stable Performance: High repeatability and resistance to interfering substances like pH variations.

Company profile

Hangzhou Singclean Medical Products Co., Ltd.

Zhejiang, China

CertifiedBusiness Type: Manufacturer/Factory & Trading Company CertifiedR&D Capacity: ODM Service AvailableExport Year: 2022-12-20 CertifiedNearest Port: Ningbo Port, Shanghai PortAverage Response Time: ≤3.11h CertifiedTerms of Payment: LC, T/T, D/P, etc.

AI-Powered supplier vetting

SummaryThe supplier is a China-based medical-products factory headquartered in Hangzhou, Zhejiang, with 420 employees and operations established in the early 2000s. It reports seven production lines, a 17,000 m² manufacturing plant, ISO 9001:2015 and ISO 14001:2015 certification, OEM/ODM services, and stated antigen rapid test-kit capacity of 10 million pieces annually. Its products and services cover in-vitro diagnostics, absorbable hemostatic products, hyaluronic-acid-related medical products, and other medical devices. The supplier reports export coverage across multiple global regions, more than 120 export destinations in a company description, and delivery within 15 working days off-peak or one month during peak periods. Evidence supports strengths in factory operations, quality systems, production scale, customization, and R&D. After-sales capability, financial credibility, and specific customer cases are not sufficiently documented in the provided slices.

Supplier typeThe supplier is identified as a manufacturing factory in Hangzhou, China, with a limited-company structure and medical-device products as its main offering. This supports classification as a direct medical-products manufacturer rather than only a trading intermediary.

CertificationsThe supplier reports ISO 9001:2015 and ISO 14001:2015 certifications, along with other unspecified certifications. These explicitly indicate documented quality-management and environmental-management systems, although the unspecified certifications cannot be assessed further.

R&D capabilityThe supplier reports dedicated R&D engineers, more than 20 years of absorbable-biomaterials expertise, a strong R&D team, and ongoing development of medical and tissue-engineering products. The slices explicitly support substantial innovation activity and industry experience.

Production capacityThe supplier reports a 17,000 m² plant, seven production lines, daily capacity of 500,000 pieces in a company description, annual antigen rapid test-kit output of 10 million pieces, and stated delivery times of within 15 working days off-peak and one month during peak season. These figures provide explicit evidence of meaningful production scale and fulfillment capability.

Customization capabilityThe supplier explicitly offers OEM and ODM services according to client needs. This is direct evidence that it can support customized product development or manufacturing arrangements.

Product Q&A

Q:What is the intended use of this test kit?

It is intended for the qualitative determination of FSH levels in women's urine to assist in pregnancy preparation, ovarian health assessment, and diagnosis of pituitary or gonadal dysfunction.

Q:How do I interpret the test results?

Positive: Two red lines (T and C) where T is same or darker than C, indicating menopause tendency. Negative: T line is lighter than C or no T line. Invalid: No red line in C region.

Q:Can this test detect pregnancy or ovulation?

No, this test is not used to determine ovulation or pregnancy. It specifically detects Follicle Stimulating Hormone (FSH) levels.

Q:What are the limitations of this test?

It is for in vitro diagnostic use only, cannot be reused, and provides preliminary qualitative detection. It cannot determine quantitative FSH values.

Q:What substances might interfere with the test results?

Substances like bleach or alum in urine, or hormone medicines affecting FSH levels, may cause false results. pH levels from 4 to 9 do not interfere.