FSH Test Kit | Menopause Self-Test | Singclean Medical
The Singclean FSH Test Kit is a rapid, CE0123-certified immunochromatographic assay for the qualitative determination of Follicle Stimulating Hormone (FSH) in women's urine. It provides actionable insights for pregnancy preparation, ovarian health assessment, and menopause diagnosis.
Intended Use & Key Applications
This IVD kit aids in the detection of pituitary and gonadal dysfunction and is designed for three primary scenarios:
Self-detection of ovarian function – Understand your ovarian reserve and reproductive status.
Guide to prevention of premature ovarian insufficiency – Early warning for declining ovarian function.
Diagnosis of menopause – Identify elevated FSH levels associated with menopause.
Product Specifications & Formats
Available in three user-friendly formats to suit different preferences and usage settings:
| Format | Packaging Specifications | Best For |
|---|---|---|
| Strip | 1T, 5T, 25T/barrel, 100T/box | Professional/clinical use, bulk screening |
| Cassette | 1T/box, 5T/box, 40T/box | Home self-testing, easy handling |
| Midstream | 1T/box, 20T/box | Most convenient for personal use |
Key Features & Benefits
CE0123 Certified – Meets European IVD safety and performance standards.
Qualitative Result in Minutes – Simple yes/no for elevated FSH (≥25 mIU/mL typically).
Room Temperature Storage – Stable at 2°C–30°C, no refrigeration needed.
Multiple Pack Sizes – Supports individual purchase, clinic bulk, or distributor wholesale.
Private Label Available – Custom packaging and branding for B2B partners.
Our Certificate
ISO
CE
Why Healthcare Professionals & Distributors Trust Singclean
Expertise: Years of IVD manufacturing experience with dedicated R&D.
Authority: CE0123 certified, following international quality management systems.
Trust: Used by hospitals, fertility clinics, and home users across multiple countries.
Support: OEM/ODM services, QC team oversight, and responsive logistics.
FAQ
Q: 1. Can I use this kit to check for menopause at home?
A: Yes. The FSH Test Kit is designed for self-detection of menopause by measuring elevated FSH levels in urine. However, consult a doctor for confirmed diagnosis.
Q: 2. How accurate is the test?
A: The kit provides high accuracy at a cut-off of 25 mIU/mL FSH, validated through clinical studies. For best results, follow instructions carefully.
Q: 3. Do you offer bulk or wholesale pricing for distributors?
A: Yes. We supply strips, cassettes, and midstream kits in bulk. Contact us for volume discounts and private labeling options.
Q: 4. What is the shelf life?
A: 24 months when stored at room temperature (2°C–30°C). Do not freeze.
Q: 5. Is CE marking included for all formats?
A: Yes, the entire FSH Test Kit range (strip, cassette, midstream) carries CE0123 certification.
Hot Tags: fsh test kit, China, manufacturers, suppliers, wholesale, over the counter face fillers, over the counter drug test, hyaluronic acid for arthritis injections, knee joint lubrication fluid, face crease filler