Singclean Wholesale Quick Results Early Result Homely Pregnant Urine Test Strip for Home Rapid Test Kit
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| Customization: | Available |
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| Type: | IVD Reagent |
| Material: | Colloidal Gold |
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Basic Info.
- Model NO.
- HCG001
- 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 Description
Ce Approved HCG Pregnancy Test Kit Urine Test Kit
Product Name
Singclean HCG Pregnancy Test Kit (Colloidal Gold)
For Self-Testing | Urine Specimen | IVD Use
Available Formats: Strip / Cassette / Midstream
Certifications: CE 0123, ISO13485
Intended Use
The Singclean Human Chorionic Gonadotropin (HCG) Pregnancy Test Kit is a rapid, one-step immunoassay for the qualitative detection of HCG in urine to aid in early pregnancy detection.
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For women planning or suspecting pregnancy
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Suitable for self-testing, professional use, and near-patient testing
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Provides early screening results in just minutes
How It Works
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Detects human chorionic gonadotropin (HCG), the hormone produced during pregnancy
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Uses colloidal gold lateral flow technology
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Visual results appear within 3-5 minutes
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Two lines (T and C) = Positive
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One line (C only) = Negative
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No line in control region (C) = Invalid, retest required
Available Formats
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Strip: Compact and economical
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Cassette: Simple operation with dropper
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Midstream: Direct use, no urine container needed
Each Kit Includes:
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1× Test Device (Strip / Cassette / Midstream)
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1× Desiccant
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1× Instruction Manual
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1× Dropper (cassette only)
Testing Procedure
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Collect fresh urine (first morning urine is recommended)
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Use the test according to the format:
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Strip: Dip for 10-15 seconds
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Cassette: Add 3 drops of urine
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Midstream: Urinate directly or dip absorbent tip
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Lay the device flat and wait 3-5 minutes
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Read the results visually
Performance Characteristics
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Sensitivity: 25 mIU/mL
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Accuracy: Over 99% agreement (450-specimen study)
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Specificity: No cross-reactivity with LH, FSH, TSH
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Consistency: Reproducible results
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No hook effect up to 200,000 mIU/mL
Product Features
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Early detection: Detect pregnancy before missed period
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Easy to use: One-step operation, no equipment needed
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Clear visual interpretation with built-in control line
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Long shelf life: 36 months
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Room temperature storage: 4-30°C
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CE 0123 certified for EU compliance
Application Scenarios
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Home use
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Pharmacy OTC retail
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Clinical use in hospitals, labs, and OB-GYN clinics
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Distributor and wholesale supply
Precautions
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For in vitro diagnostic use only
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Do not reuse components
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Do not use if foil pouch is damaged or expired
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Perform test within 60 minutes after opening
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Dispose of used test responsibly
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If symptoms persist, consult a physician for confirmation
| 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. | |
Frequently Asked Questions
Q: How soon can I test for pregnancy?
A: As early as 7 days before your expected period. First morning urine is most accurate.
Q: What does a faint line mean?
A: A faint test line still indicates a positive result. Retest in 48 hours for confirmation.
Q: Can medications affect the test?
A: Most medications do not interfere. However, fertility drugs containing HCG may cause false positives.
Q: What should I do if the result is positive?
A: Visit a doctor for confirmation and begin prenatal care.
Q: What should I do if the result is negative but my period is late?
A: Retest in 48 hours using first morning urine. If results remain negative, consult your physician.
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