CE ISO 13485 FSC Certificated AG Rapid Test Kit (Colloidal Gold) Test Kit Test Strip
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Product Highlights
- Fast Result Time: Get results in just 15 minutes for rapid diagnosis.
- High Accuracy: Features 94.17% accuracy, 88.89% sensitivity, and 97.87% specificity.
- Multiple Certifications: Certified by CE, ISO 13485, and FSC for quality assurance.
- Long Shelf Life: Valid for 2 years when stored at room temperature or refrigerated.
- OEM and ODM Services: Full customization options available for branding and packaging.
- Simple Operation: Designed for easy use with clear instructions and minimal equipment.
- Comprehensive Kit: Includes swabs, extraction tubes, buffers, and lancets for complete testing.
Product Attributes
- Customization
- Available
- Use
- Detection of Antigen in Human Body
- Speciems
- Nasopharyngeal or Throat Swabs
- Model NO.
- Cassette/card
- Packing
- Sealed Pouch and Carton
- Feature
- High Sensitivity and Specificity
- Shelf Life
- 2 Years
- Sentitivity
- 88.89%
- Specificity
- 97.87%
- Accuracy
- 94.17%
- Certificated
- CE; ISO 13485; Fsc
- Transport Package
- Carton or Customized Package
- Trademark
- Singclean or Customized brand
- Origin
- China
- HS Code
- 3002150090
- Production Capacity
- 300000/Day
Product Images of CE ISO 13485 FSC Certificated AG Rapid Test Kit (Colloidal Gold) Test Kit Test Strip
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CE ISO 13485 FSC Certificated AG Rapid Test Kit (Colloidal Gold) Test Kit Test Strip -
CE ISO 13485 FSC Certificated AG Rapid Test Kit (Colloidal Gold) Test Kit Test Strip -
CE ISO 13485 FSC Certificated AG Rapid Test Kit (Colloidal Gold) Test Kit Test Strip -
CE ISO 13485 FSC Certificated AG Rapid Test Kit (Colloidal Gold) Test Kit Test Strip -
CE ISO 13485 FSC Certificated AG Rapid Test Kit (Colloidal Gold) Test Kit Test Strip -
CE ISO 13485 FSC Certificated AG Rapid Test Kit (Colloidal Gold) Test Kit Test Strip -
CE ISO 13485 FSC Certificated AG Rapid Test Kit (Colloidal Gold) Test Kit Test Strip
Find Similar Products
Product Description
CE ISO 13485 Fsc Certificated AG Rapid Test Kit Colloidal Gold Test Kit Test Strip
Features
1. Fast: get the result in 15 mins.
2. High sensitivity and specificity.
3. Simple to use.
4. Accurate and reliable.
5. Store at room temperature
Package Contents
One Step Rapid Test Kit Nasal Swab
1 Instruction
1 Paper Workbench
20 Test Kits
20 Swabs
20 Extraction Tubes and Dropper Tips
1 Bottle of Extraction Buffer 5ml
1 test/kit: 400 pcs/carton, L520*W380*H500mm
1 Instruction
1 Test Kit
1 Swab
1 Extraction Tube and Dropper Tip
1 Extraction Buffer
IgG/IgM Antibody Rapid Test Kit Blood Test
1 Instruction
5 Buffers
20 Test Kits
20 Lancets
20 Disposable Micropipettes
20 Alcohol Tablets
1 test/kit: 500 pcs/carton, L680*W530*H400mm
1 Instruction
1 Buffer
1 Test Kit
1 Lancet with Instruction
1 Disposable Micropipette
1 Alcohol Tablet
Materials Supplied
20 sealed pouches each containing a test cassette, a dropper and a desiccant
Buffer
1 package insert
1 alcohol pad for disinfection use
1 Lancet (for fingerstick whole blood only)
Material Required But Not Provided
1. Centrifuge (for plasma only)
2. Timer
3. Heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)
Clinical Data
Storage And Stability
The kit can be stored at room temperature or refrigerated (4-30°C). The test device is stable through the expiration date printed on the sealed pouch. The test device must remain in the sealed pouch until use. DO NOT FREEZE. Do not use beyond the expiration date.
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.
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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
- How long does it take to get results?
- You can get the result in 15 minutes.
- What is the shelf life of the test kit?
- The shelf life is 2 years.
- What are the accuracy and sensitivity rates?
- The kit has 94.17% accuracy, 88.89% sensitivity, and 97.87% specificity.
- What certifications does the product have?
- The product is certified by CE, ISO 13485, and FSC.
- Can I customize the packaging or branding?
- Yes, full customization options including OEM and ODM services are available.
- What is the minimum order quantity?
- The minimum order quantity is 10 pieces.
- What is the lead time for production?
- Peak season lead time is one month, while off-season lead time is within 15 workdays.
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