Disposable Bacterial Vaginosis Rapid Diagnostic Test
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Product Highlights
- Comprehensive BV Screening: Detects H2O2, pH, SNa, and LE to screen for bacterial vaginosis.
- Dry Chemical Enzymatic Tech: Utilizes dry chemical enzymatic detection for accurate results.
- Two-Year Quality Guarantee: Backed by a solid two-year quality guarantee period.
- Full Customization Options: Supports full customization including logo and packaging.
- ISO9001 Certified Manufacturer: Produced by a factory with ISO9001:2015 management certification.
- 100% Finished Product Inspection: Ensures quality through visual and functional 100% inspection.
- OEM/ODM Service Available: Offers both OEM and ODM services for brand partners.
- Global Supply Capability: Exports to North America, Europe, Asia, Africa, and Australia.
Product Attributes
- Customization
- Available
- Type
- Test Strips & Test Tube
- Ethylene Oxide Sterilization
- Without Ethylene Oxide Sterilization
- Quality Guarantee Period
- Two Years
- Group
- Adult
- Logo Printing
- Without Logo Printing
- Material
- Dry Chemical Enzymatic Detection
- Transport Package
- Box
- Specification
- 20pcs/box; 50pcs/box.
- Trademark
- Quickclean or customized brand
- Origin
- China
- HS Code
- 3822001000
- Production Capacity
- 10000boxes/Month
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Product Description
Disposable Bacterial Vaginosis Rapid Diagnostic Test
Overview
Bacterial Vaginosis is a condition in which the amount of lactobacilli in the patient's vagina reduces while the pathogenic bacteria multiply, causing the reduction of hydrogen peroxide concentration and rising pH; Besides, the pathogenic bacteria produce large amounts of neuraminidase 100-1000 times higher than that of normal level. This product, making a primary screen of bacterial vaginosis through the detection of hydrogen peroxide, neuraminidase, leukocyte esterase and pH in the vaginal discharge, conducts auxiliary diagnosis of bacterial vaginosis infection.
Scope of Application
For the screening of bacterial vaginosis, auxiliary diagnosis and reatment evaluation.
Product Description
Bacterial Vaginosis diagnostic kit sets (dry chemical enzymatic detection), is an in vitro diagnostic reagents products to test female bacterial vaginosis. Through testing the H2O2, pH value, SNa and LE, the four indicators of female vaginal discharge, evaluate comprehensively, and get the result, it has certain guiding significance for the clinical diagnosis.
Product Application
Used to assist the diagnostic of bacterial vaginosis, evaluate the micro ecological balance in genital tract, and so to prevent the repeatdisease of vaginosis.
| Brand | Specification | Specification |
| Quickclean | 20 PCS/box | 50 PCS/box |
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
-
QA/QC inspectors
- 66 people
-
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
-
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
-
Overseas Agent/Branch
- Yes
-
New Products Launched in Last year
- Yes
Our Certifications, Standards & Industry Recognition
-
Management System Certification
- ISO9001:2015, Others
-
Product Certification
- CE
-
Cooperated with Fortune 500
- No
FAQ
- What indicators does the test detect?
- It detects hydrogen peroxide (H2O2), pH value, neuraminidase (SNa), and leukocyte esterase (LE) in vaginal discharge.
- What is the minimum order quantity?
- The minimum order quantity is 10 pieces.
- Is the product sterilized with Ethylene Oxide?
- No, the product is without Ethylene Oxide Sterilization.
- What are the available packaging specifications?
- Available specifications are 20 pieces per box and 50 pieces per box.
- What is the lead time for production?
- Peak season lead time is one month, while off-season lead time is within 15 workdays.
- Does the manufacturer support customization?
- Yes, full customization is available, including logo printing and packaging options.
- What payment terms are accepted?
- Accepted payment terms include LC, T/T, D/P, PayPal, Western Union, and small-amount payment.
- What is the warranty period for this product?
- The quality guarantee period is two years.
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