Ovulation Test Plus a Pregnancy Test First Response
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Product Highlights
- Comprehensive Certification: CE, MSDS, and ISO13485 certified for global compliance and safety.
- Full Customization Options: Offers full customization including logo printing and tailored specifications.
- OEM and ODM Services: Supports both OEM and ODM services with 22 dedicated R&D engineers.
- High-Quality Manufacturing: 100% visual and functional inspection by 66 QA/QC inspectors ensures reliability.
- Flexible Payment Terms: Accepts LC, T/T, D/P, PayPal, Western Union, and small-amount payments.
- Global Market Reach: Exports to North America, Europe, Southeast Asia, Middle East, Africa, and Australia.
- Fast Lead Time: Off-season lead time within 15 workdays; peak season within one month.
- Traceable Raw Materials: Full traceability of raw materials ensures product quality and safety.
Product Attributes
- Customization
- Available
- Type
- IVD Reagent, Ivd Reagent
- Material
- Plastic
- Model NO.
- FT-L21
- Size
- 140mm*4.5mm
- Ethylene Oxide Sterilization
- Without Ethylene Oxide Sterilization
- Quality Guarantee Period
- Two Years
- Logo Printing
- with Logo Printing
- Function
- Lh Test
- Use
- Female
- Classification
- Biological Diagnostics
- Certification
- CE, MSDS, ISO13485
- Group
- Adult, Female
- Transport Package
- Box
- Specification
- 100pcs/box, 50pcs/box, 1pcs/box
- Trademark
- Singclean
- Origin
- China
- HS Code
- 38220090
- Production Capacity
- 1800000PCS/Year
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Product Description
Ovulation Test Plus a Pregnancy Test First Response
The FSH(Follicle Stimulating Hormone) rapid test dipstick is a rapid test that qualitatively detects the FSH level in unrine specimen at the sensitivity of 25mIU/ml. The test utilizes a combination of antibodies including a monoclonal anti-FSH antibody to selectively detect elevated levels of FSH.
Application
The FSH Rapid Test Dipstick ( Urine) is a repid chromatographic immunoassay for the qualitative detection of follicle stimulating hormone(FSH) in urine to aid in the detection of menopause.
1.Self-detection of ovarian function
2.Prevention of premature ovarian
3.Diagnosis of menopause
Direction of Use
Allow the test, urine specimen and /or control to reach room temperature(15-30ºC) prior to test in.
-
Determine the day to begin test.
-
Bring the pouch or canister to room temperature before opening it. Remove the test Dipstick from the sealed pouch or closed canister and use it as soon as possible.
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With arrows pointing toward the urine specimen for at least 15 seconds. Do not pass the maximum line (MAX) on the test Dipstick when immersing the Dipstick. See illustration below.
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Place the test Dipstick on a non-absorbent flat surface, start the timer and wait for the colored line(s) to appear. The result should be read at 3 minutes
INTERPRETATION RESULT (Please refer to the illustration)
Positive: Two lines are visible and the line in test line region(T) is the same as or darker than the line in the control line region(C). A positive result means that the FSH level is higher than normal. Record the results and see the chart below to interpret result.
Negative: Two lines are visible, but the line in the test line region(T) is lighter than the line in the control line region(C), or there is no line in the test line region (T). A negative result means that the FSH level is not elevates at this time. Record the results and see the chart below to interpret result.
Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control the failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
Test Interpretation
Review the result of both tests ( if applicable) and interpret according to the chart below.
For patients experiencing premenopausal symptoms plus irregular menstrual cycles:
|
1st test |
2nd test |
Interpretation |
|
Positive |
Positive |
Most likely in perimenopause. Discuss with patient methods and therapies to promote good health after menopause. Patient should NOT immediately discontinue contraception. |
|
Positive |
Negative |
May be in early stages of perimenopause. Patient should NOT immediately discontinue contraception. |
|
OR |
||
|
Negative |
Positive |
|
|
Negative |
Negative |
Most likely not experiencing perimenopause this cycle. If symptoms persist, repeat patient testing in the following month or review other possible causes for symptoms. |
For the patients experiencing menopausal symptoms who have had NO menstrual cycle for the past 12months:
|
1st Test |
Interpretation |
|
Positive |
Menopause has most likely occurred. Test may be repeated. Discuss with patient methods and therapies to promote good health after menopause. |
About the Supplier
This supplier has been audited by BV. Verify the report on the official BV website with ID "MIC-ASR2532126". Items marked "" are certified.
Company Profile
Company Introduction
Hangzhou Singclean Medical Products Co., Ltd., established in March 2002 with registered capital of 80, 000, 000 RMB, is a national high and new technology enterprise integrating the R&D, production and sales of medical biomaterials.With highly-qualified staff, thorough quality management system and first-class facilities, the company ensures the continuous production of medical devices and drug injection products of Class III that conform to the laws and regulations of National Medical Products Administration (NMPA) and EU MDR.
Cooperation
The company set up a joint research center with Zhejiang University of Science and Technology, and has well established R&D cooperation relations with Zhejiang University, Donghua University and Zhejiang University of Technology, developing four series of new products with proprietary intellectual property rights, and with a variety of high-tech products to be developed cooperatively.The company also built an R & D platform for medical biomaterials that keeps up with the international level, and made major breakthrough in many key technologies such as those for stopping bleeding, anti-adhesion, and tissue engineering basic materials, with more than 55 patents obtained and a number of products applying for the patents.
Our manufacturing
The company's plant in Xiasha covers the construction area of 174014.83 m²And producing tract of 13, 200 m²Including cleanrooms of 2, 300 m²In which cleanroom of Class C covers 2, 000 m²And that of Class B covers 300 m²With over 60 m²Of which follows into Class A.A new cleanroom up to GMP standard was set up in this plant, and the Pharmaceutical Production License was obtained in 2012.It will produce all kinds of medical equipment and medical 10 million sets, production value 2 billion, In addition, the plant has introduced more production facilities such as the Invoa filling machine from Germany, the sterilizer from GETINGE, the semi-automatic filling and sealing equipment from Pluemat, 5T / h purified water machine, 3T / h water for injection machine, and 1T / h of pure steam generator.
Quality system
Respect for life strict quality control
The company has set up a documentation-based GB/T19001-2008, YY/T0287-2003, Good manufacturing Practice for medical devices, Good manufacturing practice for In vitro diagnostic reagents, good manufacturing practice of drug, 2010, medical device directive (MDD93/42/EEC ), according to quality objectives, auit resullt, data analysis, corrective and preventive actions and management review, in order to maitain the continued suitability and effectivenss of the quality managenment system.
Technological Innovation
Cohesion of technological strength improving core competitiveness
The company has been always laid stress on product rsearch and development, investing annually 10% of the sales to comstruction of R&D center, new product development and introduction of advance equipments.The R&D center is equipped with cleanroom in Class 10000(including Class 100) of more than 200m², and it has acquired a number of patent technologies.
Product center
Committing herself to develop new types of composite and smart biomaterials, the company majors in producing biodegradable bio-materials and their derivatives, and has at present products of 8 series (chitosan, medical sodium hyaluronate gels, cross-linked hyaluronic acidsodium gels, microporous polysaccharide, oxidized regenerated cellulose, basic materials of tissue engineering, in vitro diagnostic reagents), 50 varieties of cosmetics are being exported to more than 120 countries around the world, such as:Italy, Russia, Turkey, France, Brazil, Chile, Australia, and Canada.Until now, Singclean has got 30+ CE certificates, 16 medical device registration certificates and 46 patent certificates.At Singclean, all their 600 employees are working with the best and committed to excellence.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- No. 125(E), 10th Street, Hangzhou Qiantang Area, China 310018, Hangzhou, Zhejiang, China
-
Plant Area
- 13045 square meters
-
Number of Employees
- 546
-
Registered Capital
- 80,000,000 RMB
-
Terms of Payment
- LC, T/T, D/P, PayPal, Western Union, Small-amount payment
-
International Commercial Terms(Incoterms)
- FOB, CIF, CFR, EXW
-
Average Lead Time
- Peak Season Lead Time, one month, Off Season Lead Time, within 15 workdays
-
Nearest Port
- Shanghai Port
-
Minimum Order Quantity
- 10 PCS
-
Supply Chain Partners
- 260
Our Production Capability & Technical Expertise
-
Main Products
- Dermal Filler, Joint Lubrication for Knee, Cross-Linked Sodium Hyaluronate Gels, Absorbable Hemostatic Particles, Oxidized Regenerated Cellulose, Poly-L-Lactic Acid Filler For Injection
-
Production Lines
- 10
-
Production Machines
- Testing Machine
-
Inspection Type for Finished Products
- 100% inspection Visual inspection Function inspection
-
Inspection Method for Finished Products
- Finished product checked by packing staff
-
Customization Options
- Full Customization
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 22 people
-
Traceability of Raw Materials
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2003-03-25
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Export Year
- Shanghai Port
-
Main Markets
- North America, Europe, Southeast Asia/ Mideast, Africa, Australia, Domestic
-
Repeat Buyers Choice
- 50%~80%
-
Number of Foreign Trading Staff
- 54
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Overseas Agent/Branch
- Yes
Our Certifications, Standards & Industry Recognition
-
Management System Certification
- ISO9001:2015, Others
-
Cooperated with Fortune 500
- No
FAQ
- What certifications does the product have?
- The product is certified with CE, MSDS, and ISO13485 to ensure international safety and compliance standards.
- Can I customize the product with my logo?
- Yes, full customization is available, including logo printing and tailored product specifications.
- What are the payment terms?
- We accept various payment methods including LC, T/T, D/P, PayPal, Western Union, and small-amount payments.
- How long is the lead time for production?
- The lead time is within 15 workdays during off-season and one month during peak season.
- Do you offer OEM and ODM services?
- Yes, we provide both OEM and ODM services supported by a team of 22 R&D engineers.
- What is the minimum order quantity?
- The minimum order quantity is 10 pieces.
- How do you ensure product quality?
- We perform 100% visual and functional inspection on finished products conducted by 66 QA/QC inspectors.
- Where do you ship your products?
- We export to North America, Europe, Southeast Asia, Middle East, Africa, Australia, and domestic markets.
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