HCG Early Pregnancy Test Kit Strip, Cassette and Midstream Diagnosis with CE
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Product Highlights
- High Sensitivity Detection: Sensitivity of 10, 20, and 25 mIU/mL for effective early pregnancy detection.
- Multiple Format Options: Available in Strip, Cassette, and Midstream formats to suit various needs.
- OEM Customization Available: OEM packing and logo printing services are accepted for bulk orders.
- High Accuracy Rate: Provides over 99% accuracy in qualitative detection of hCG in urine.
- ISO and CE Certified: Certified with CE 0123, ISO 9001, and ISO 13485 standards.
- Flexible Lead Time: Sample delivery next day or within 7 days depending on stock availability.
- Versatile Strip Sizes: Strip widths available in 2.5mm, 3.0mm, 3.5mm, 4.0mm, 5.5mm, and 6.0mm.
Product Attributes
- Customization
- Available
- Type
- IVD Reagent, Ivd Reagent
- Ethylene Oxide Sterilization
- Without Ethylene Oxide Sterilization
- Quality Guarantee Period
- Two Years
- Group
- Adult
- Logo Printing
- Without Logo Printing
- Material
- Colloidal Gold
- Certificates
- ISO13485/Cecfda
- Principle
- Colloidal Gold Method
- Specimen
- Urine
- Form
- Strip/Cassette/Uncut Sheet/Device/Midstream/Canist
- Brand Name
- Singclean
- Strip
- 2.5mm/3.0mm/3.5mm
- Storage
- Room Temperature
- Packing
- 1test/Pouch
- Sellf Life
- 2 Years
- Transport Package
- Cartons
- Specification
- 0.14M
- Trademark
- OEM
- Origin
- China
- HS Code
- 3302100090
- Production Capacity
- 5000/Day
Product Images of HCG Early Pregnancy Test Kit Strip, Cassette and Midstream Diagnosis with CE
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HCG Early Pregnancy Test Kit Strip, Cassette and Midstream Diagnosis with CE -
HCG Early Pregnancy Test Kit Strip, Cassette and Midstream Diagnosis with CE -
HCG Early Pregnancy Test Kit Strip, Cassette and Midstream Diagnosis with CE -
HCG Early Pregnancy Test Kit Strip, Cassette and Midstream Diagnosis with CE -
HCG Early Pregnancy Test Kit Strip, Cassette and Midstream Diagnosis with CE -
HCG Early Pregnancy Test Kit Strip, Cassette and Midstream Diagnosis with CE -
HCG Early Pregnancy Test Kit Strip, Cassette and Midstream Diagnosis with CE
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Product Description
HCG Early Pregnancy Test kit strip, cassette and midstream format with CE
The Human Chorionic Gonadot (hCG) Pregnancy Test Kit is a rapid, one-step lateral flow immunoassay for the qualitative determination of hCG in human urine specimens, to aid in the early detection of pregnancy.
HCG tests are available in strip, cassette and midstream format.
1.This convenient test has a sensitivity of 10, 20, 25mIU/mL, making it an effective aid in early detection of pregnancy.
2.The One-Step hCG Pregnancy Test is suitable for both professional and home use.
3.Packing: individual foil pouch package, 1pc/box, OEM packing is accepted.
Product Packing
More details information:
| Product Code | HCG pregnancy Test Kit |
| Brand Name | Singclean® |
| Format | A. Strip(dipstick) |
| B. Cassette(card) | |
| C. Midstream(pen/pencil plus) | |
| Methodology | Colloidal Gold |
| Product Formation | 1. Test strip/Test cassette/Test midstream |
| 2. Dropper(for test cassette) | |
| 3. Desiccant | |
| 4. Instruction for use | |
| Assay Type | Qualitative Detection |
| Specimen | Urine |
| Indicator | Human Chorionic Gonado--n (HCG) |
| Detection Limits | 25 mIU/ml for urine test |
| Specification | A.Strip: 2.5 mm; 3.0 mm; 4.0 mm |
| B.Cassette: 3.0 mm, 4.0 mm | |
| C.Midstream: 3.5 mm; 5.5 mm; 6.0 mm | |
| Packing (OEM packing are also available) | A. Strip:1 test in a single pouch, 100 tests in a box, 3000 tests in a carton |
| B. Cassette: 1 test in a single pouch, 50 tests in a box, 1000 tests in a carton | |
| C. Midstream: 1 test in a single pouch, 2000 pcs in a carton or 1 test in a single pouch, 1 test per box, 414 tests in a carton | |
| Certificates | CE 0123, ISO 9001,ISO 13485 |
| Accuracy | Over 99% |
| Storage Temperature | 4-30 degree centigrade |
| Shelf Life | 36 months |
| Sample Lead time | The next day after we receive your freight; Or within 7 days if we don't have stocks for some special specification. |
| Customer LOGO | OEM Logo available |
| Loading Port | Shanghai, Ningbo |
| Our main products: HCG pregnancy test, LH Ovulation test, FSH menopause test, MAU Diabetic Nephropathy/Renal Dysfunction Rapid Test, NGAL Kidney Injury Rapid Test,BV Bacterial Vaginosis rapid test, AFP (AFP) Alpha-Fetoprotein Elisa Hepatocellular Carcinoma Test, DOA Drug of Abuse test and etc. | |
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
-
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
Our Certifications, Standards & Industry Recognition
-
Management System Certification
- ISO9001:2015, Others
-
Cooperated with Fortune 500
- No
FAQ
- What formats are available for the HCG test kit?
- The HCG test kit is available in Strip, Cassette, and Midstream formats.
- What is the sensitivity of the test?
- The test has a sensitivity of 10, 20, and 25 mIU/mL.
- Is OEM service available?
- Yes, OEM packing and logo printing are accepted.
- What is the shelf life of the product?
- The shelf life is 36 months when stored at room temperature.
- What certifications does the product have?
- The product is certified with CE 0123, ISO 9001, and ISO 13485.
- How long is the sample lead time?
- Samples are ready the next day after receiving freight, or within 7 days if stock is available.
- What is the minimum order quantity?
- The minimum order quantity is 10 pieces.
- What is the accuracy rate of the test?
- The test provides an accuracy rate of over 99%.
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