HCG Pregnancy Rapid Test Strip Urine/Serum Colloidal Gold Kit
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Product Highlights
- High Accuracy: Accuracy rate of 0.99 for reliable early pregnancy detection.
- Rapid Detection: Results available within 1 minute with clear visual bands.
- Dual Specimen Support: Compatible with both urine and serum samples for flexibility.
- ISO 13485 Certified: Manufactured under ISO 13485 quality management standards.
- Ethylene Oxide Free: Sterilized without ethylene oxide for enhanced safety.
- 3-Year Quality Guarantee: Comprehensive 3-year quality assurance period provided.
- OEM/ODM Services: Customization services available for logos and packaging.
- Low Sensitivity Threshold: Detects HCG levels as low as 10-25 mIU/ml.
Product Attributes
- Customization
- Available
- Applicable Stage
- Early Pregnancy
- Accuracy
- 0.99
- Model NO.
- HPRTS
- Detection Time
- 1 Minute
- Product Type
- Strip
- Certificate
- Iso13485
- Ethylene Oxide Sterilization
- Without Ethylene Oxide Sterilization
- Group
- Women
- Material
- PVC
- Quality Guarantee Period
- 3 Year
- Logo Printing
- Both
- Type
- Disposable Medical Test
- Transport Package
- Cartons
- Specification
- 2.5mm
- Trademark
- No
- Origin
- China
- HS Code
- 3822190090
- Production Capacity
- 10000000000PCS/Year
Product Images of HCG Pregnancy Rapid Test Strip Urine/Serum Colloidal Gold Kit
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HCG Pregnancy Rapid Test Strip Urine/Serum Colloidal Gold Kit -
HCG Pregnancy Rapid Test Strip Urine/Serum Colloidal Gold Kit -
HCG Pregnancy Rapid Test Strip Urine/Serum Colloidal Gold Kit -
HCG Pregnancy Rapid Test Strip Urine/Serum Colloidal Gold Kit -
HCG Pregnancy Rapid Test Strip Urine/Serum Colloidal Gold Kit -
HCG Pregnancy Rapid Test Strip Urine/Serum Colloidal Gold Kit -
HCG Pregnancy Rapid Test Strip Urine/Serum Colloidal Gold Kit
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Product Description
Positive: In addition to the control band, a distinct colored band also appears in the test region.
Invalid: If no bands appear, or a test band appear with out a control band, the test shoud be repeated using a new test cassette.
Note:
Test must be in room temperature (10oC to 30oC)
1. Open the sealed pouch by tearing along the notch. Remove the test device from the pouch.
2. Hold the one side of the device with one hand. Use the other hand to pull out the cap and
expose the absorbent end.
3. Immerse the absorbent end into the urine sample about 10 seconds. Make sure that the urine
level is not above the "MAX" line printed on the front of the device.
4. Lay the device flat on a clean, dry, non-absorbent surface.
5. Read the result at 5 minutes. Do not read after 5 minutes.
INTENDED USE
The HCG test is a chromatographic immunoassay for the early detection of human chronic Gonadotropin(HCG) in urine and serum.
HCG is a glycoprotein hormone secreted by the developing placenta during pregnancy. The concentration of HCG in serum is approximately equal to the concentration of HCG in urine. The concentrations of HCG in urie and serum continue to rise during the first trimester of pregnancy to as high as 100,000 mIU/ml HCG test shows no cross-reactivity with structurally related hormones (FSH, LH, TSH) in normal maximum physiological concentration.
| Format | Specimen | Sensitivity | Size(mm) |
| Strip | Urine/Serum | 10-25mIU/ml | 2.5,3.0,3.5 |
| Cassette |
Urine/Serum |
10-25mIU/ml | 3.0,4.0 |
| Midstream | Urine/Serum | 10-25mIU/ml | 4.5,5.5,6.0 |
1.Remove the test cassette from pouch by tearing the foil pouch.
2.Draw specimen (urine or serum) into dropper and dispense it into the sample well on the cassette (2-3 drops, approximately 100ul). Be careful not to overfill the absorbent pad.
3.Read results within five minutes.
4.Discard the test device after a single use.
Depending on the concentration of HCG in the urine sample, positive results may be seen within 40 seconds. Wait the full five minutes to confirm the result. Do not read the Cassette Test after 5 minutes as this may also give an incorrect test result.
Negative: Only one colored band appears on the control region. No colored band in the test region.
Positive: In addition to the control band, a distinct colored band also appears in the test region.
Invalid: If no bands appear, or a test band appear with out a control band, the test shoud be repeated using a new test cassette.
About the Supplier
This supplier has been audited by SGS. Verify the report on the official SGS website with ID "QIP-ASR2641052". Items marked "
" are certified.
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Company Profile
Glob Biotech is a professional manufacturer dedicated to the research, development and production of rapid diagnostic tests, with over 20 years of mature experience in the IVD industry. Our production base is located in Nantong, a core city within Shanghai's one-hour economic circle. Our standardized factory covers an area of more than 4, 000 square meters, equipped with complete automated production lines, sterile packaging workshops, independent laboratories and dedicated storage zones. Every production procedure follows standardized management, forming a complete industrial chain from raw material inspection to finished product delivery. Supported by sufficient production facilities, we maintain stable mass output capacity, capable of fulfilling small trial orders, bulk wholesale orders and customized OEM batches while guaranteeing on-time delivery and consistent product quality. Quality management stands at the heart of our operation. Our factory and all product lines have passed authoritative international certifications including GMP, ISO13485 for medical devices. We carry out strict full-process quality control: Every batch of raw materials, semi-finished goods and finished rapid test kits undergoes rigorous sensitivity, specificity and stability testing before shipment. Our product portfolio covers a full range of rapid immunoassay products, including Fertility test, infection disease test and drug test, meeting diverse self-test and auxiliary clinical testing demands worldwide. We own the self-developed brand "Glob Biotech" and sincerely invite global distributors, pharmacy chains and cross-border e-commerce sellers to become our exclusive regional brand agents. We provide comprehensive brand support for authorized partners: Free complete certification documents, multilingual marketing materials, exclusive regional sales policies, one-on-one product and sales training, and continuous new product updates. We customize targeted agency plans according to your market scale and channel layout, helping you rapidly expand local market share with our recognized brand. Besides brand distribution, we offer flexible full-set OEM & ODM customization services to satisfy differentiated market demands. We support tailor-made adjustments covering packaging design, product specifications, test formats and appearance shapes. Clients can customize outer cartons, individual foil pouches and manuals with exclusive logos and multilingual texts; We also supply test strips, midstream pens and test cassettes with adjustable box quantities from 1-piece retail packs to 100-piece bulk cartons. Our professional international sales team possesses rich experience in medical foreign trade, familiar with customs clearance, overseas regulatory policies and after-sales technical support. We maintain efficient communication for all inquiries about quotations, samples, certifications and cooperation solutions. Upon request, we can provide detailed market analysis and operational suggestions to reduce your market trial-and-error costs. We always stick to two core operational principles: Supplying premium-quality products at factory-direct competitive prices, and pursuing stable, long-term win-win cooperation rather than short-term one-off deals. As a direct manufacturer without intermediate links, we cut redundant costs and deliver transparent pricing while never compromising quality. We treat every partner equally, adjusting cooperation schemes flexibly to achieve mutual growth. If you are seeking a certified, reliable rapid test manufacturer and brand supplier, feel free to contact our professional team. We will provide full product samples, complete qualification files and personalized cooperation proposals, joining hands with you to tap the huge potential of the global in vitro diagnostic market and realize sustainable shared development.
About Our Factory & Business Background
-
Business Type
- Manufacturer/Factory & Trading Company
- Address
- Unit 1, Building 3, No. 259, Shibei Gaoxin Road, Tangzha Town Street, Nantong, Jiangsu, China
-
Plant Area
- 1250 square meters
-
Number of Employees
- 15
-
Terms of Payment
- 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: within 15 workdays
Off Season Lead Time: within 15 workdays -
Nearest Port
- Shanghai Port
-
Minimum Order Quantity
- 1000 Pcs
-
Supply Chain Partners
- 18
Our Production Capability & Technical Expertise
-
Main Products
- Pregnancy Test, Pregnancy Test Kit
-
Production Machines
- Assemble Line, Centrifuge Machine, Cutting Machine, Sealing Machine, Membrane Apparatus, Weight and Mixing Machine
-
ODM Service Available
- Yes
-
OEM Service Available
- Yes
-
R&D Engineers
- 1 people
-
Own Brand
- Yes
Our Industry Experience & Global Business Record
-
Year of Establishment
- 2018-04-28
-
Export Year
- 8 Years
-
Main Markets
- South America
-
Number of Foreign Trading Staff
- 2
-
Overseas Agent/Branch
- No
FAQ
- What is the accuracy of the test?
- The test has an accuracy rate of 0.99.
- How long does it take to get results?
- Detection time is 1 minute, with results readable at 5 minutes.
- Can this test be used with serum?
- Yes, the kit supports both urine and serum specimens.
- Is the product certified?
- Yes, it holds ISO 13485 certification.
- What is the warranty period?
- The quality guarantee period is 3 years.
- Does the test contain ethylene oxide?
- No, the product is sterilized without ethylene oxide.
- Is customization available?
- Yes, OEM and ODM services including logo printing are available.
- What is the sensitivity of the test?
- The sensitivity is 10-25 mIU/ml.
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