Singclean China Supplier CE Approved Wholesale Rapid Medical Supply Ivd Reagent Diagnostic Urine Ovulation Pregnancy Test for Home
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Product Highlights
- High Accuracy Rate: Over 99% accuracy for reliable pregnancy detection results.
- Rapid Detection Time: Provides results within 1-3 minutes for quick decision making.
- Multiple Formats Available: Offered in Strip, Cassette, and Midstream formats to suit different needs.
- OEM Branding Support: Customized logo printing and OEM packing options are accepted.
- Long Shelf Life: 36 months shelf life ensures product stability and usability.
- CE and ISO Certified: Certified with CE 0123, ISO 9001, and ISO 13485 standards.
- Sensitive Detection: Detects hCG levels as low as 10-25 mIU/mL for early pregnancy.
- Fast Sample Lead Time: Ready to ship the next day or within 7 days depending on stock.
Product Attributes
- Customization
- Available
- Type
- IVD Reagent
- Material
- Colloidal Gold
- Quality Guarantee Period
- Three Years
- Group
- Female
- Use
- Home or Hospital Use
- Types
- Strip/Midstream/Cassette
- Logo Printing
- Singclean or Customized Brand
- Packing
- Box and Carton
- Shipment
- by Air or by Sea
- Accuracy
- Over 99%
- Read Time
- Within 1-3 Mintues
- Features
- Precise; Rapid; Sensitive
- Transport Package
- Carton or OEM
- Specification
- 2.5mm; 3mm; 3.5mm; 5.5mm; 6.0mm
- Trademark
- Singclean or Customized
- Origin
- China
- HS Code
- 3822001000
- Production Capacity
- 10000/Day
Product Images of Singclean China Supplier CE Approved Wholesale Rapid Medical Supply Ivd Reagent Diagnostic Urine Ovulation Pregnancy Test for Home
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Product Description

Ce Approved HCG Pregnancy Test Kit Urine Test Kit
Intended Use
(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
Product 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 |
| 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-ASI2232095". Items marked "" are certified.
Company Profile
Founded in 2002, Singclean Medical has been dedicated to the innovation of absorbable biomaterials, and now has 20 years of expertise in the industry of absorbable biomaterials and ranks among the top 3 Chinese Manufacturer and one of the world's leading innovators in this industry.
Singclean has evolved from device makers to problem solvers. We provide 8 series of products (medical sodium hyaluronate gel products, chitosan products, cross-linked sodium hyaluronate gel products, microporous polysaccharide products, oxidized regenerated cellulose products, in vitro diagnostic reagent products, collagen sponge, regenerative medicine engineering basic material products) with 50 varieties which are exported to more than 120 countries, such as: Italy, Germany, Turkey, Thailand, Brazil, Chile to improve quality of life for patients in the world.
Our Mission
Singclean is always focusing on absorbable biomaterials innovation and committed to providing safer and more efficient solutions. Together with all the staff from Singclean, we work to perfect our products and service on a daily basis.
Our Vision
To be the leading manufacturer of absorbable biomaterials in the world.
Innovation Drives Our Growth
Singclean has a strong research and development team with more than 60 experienced engineers. Each year, over 9 million euros is invested into R&D to create pioneering medical products, like tissue engineering products.
To Put Quality at the First Place
Singclean Medical accepts and passes over 10 times unannounced foreign and domestic inspections each year. And it has always put quality at the first place. High-precision analytical instruments like GC, GCMS, TA rheometer, and Malvern particle size analyzer are used by our skilled staff to carry out tests for incoming and outgoing quality control.
To Meet All Your Manufacturing Needs
A standardized workshop covering an area of 43 acres 7 purification workshops designed according to GMP standards cleanrooms ranging from class 100, 000 to class 100, together with highly skilled workers and advanced production lines to bring a daily production capacity of 500, 000 PCS. OEM and ODM service are available to according to clients' needs.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- No. 125, 10th Street (East), Qiantang New District, Hangzhou, Zhejiang, China
-
Plant Area
- 17000 square meters
-
Number of Employees
- 420
-
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
- Ningbo Port, Shanghai Port
Our Production Capability & Technical Expertise
-
Main Products
- In Virto Diagnostic Test Kit, Medical Sodium Hyaluronate Gel, Hyaluronic Acid Dermal Filler, Hemostatic Products
-
Production Machines
- Filling Facility, Packaging Facility, Sterilization Facility
-
ODM Service Available
- Yes
-
R&D Engineers
- 24 people
-
Own Brand
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2003-03-25
- Export Year
- 2022-12-20
-
Main Markets
- North America, South America, Europe, Southeast Asia/ Mideast, Africa, East Asia(Japan/ South Korea), Australia, Domestic
-
Number of Foreign Trading Staff
- 50
-
Overseas Agent/Branch
- No
Our Certifications, Standards & Industry Recognition
-
Product Certification
- CE
FAQ
- What formats are available for the HCG test kit?
- The HCG test kit is available in three formats: Strip, Cassette, and Midstream.
- How accurate is the pregnancy test?
- The test offers an accuracy rate of over 99%.
- How long does it take to get results?
- Results are available within 1 to 3 minutes.
- Can I customize the brand logo and packaging?
- Yes, we offer customized logo printing and OEM packing services.
- What is the shelf life of the product?
- The product has a shelf life of 36 months.
- What is the lead time for sample orders?
- Samples are ready the next day after receiving freight, or within 7 days if special specifications are out of stock.
- What certifications does the product hold?
- The product is certified with CE 0123, ISO 9001, and ISO 13485.
- Where is the product shipped from?
- Products are shipped from Shanghai or Ningbo ports.
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