Ce and FDA Approved Rapid Diagnostic HCG Cassette Test Kit

Customization: Available
Type: IVD Instrument
Sensitivity: 10 Miu/Ml;15miu/Ml;25miu/Ml

Product Description

📊 Basic Information
Model NO.
RH-HCG-C
Accuracy
More Than 99%
Shelf Time
24-36 Month
OEM Time
15-35 Days
Certificate
CE/ISO13485/FDA
Specimen
Urine, Serum
Format
Strip /Cassette /Midstream
Specification
2.8mm/3.0mm/4.0mm
Production Capacity
400,000 Pcs/Day
📝 Product Description

The One Step hCG test is a rapid test to detect the presence of HCG in urine or serum specimens in a qualitative format sensitive to 15mIU HCG/ml. The test utilizes a combination of monoclonal and polyclonal antibody reagents to selectively detect elevated level of HCG. The immunological specificity virtually eliminates cross reactivity interferences from structurally related hormones like hFSH, hLh, and hTSH.

  • Easy to use
  • Easy to read
  • Test any time of day
  • Early detection (1 day after missed period)
  • Room temperature storage
Product Format Technical Specs
⚙️ How to Operate
1. Open the sealed pouch by tearing along the notch and remove the test cassette.
2. Draw 3 drops of urine sample into the pipette and dispense it into the sample window (S).
3. Wait for 5 minutes to read results. Do not read after 15 minutes.
Operation Steps
🔍 Result Interpretation

• Negative: One red line in control area (C) - Not pregnant.

• Positive: Two red lines (Both C and T areas) - Pregnant.

• Invalid: No color lines appear - Procedure error or reagent deterioration.

Final Result Guide
❓ FAQ
Q1: How accurate is the hCG Pregnancy Test?
The test is proven to be more than 99% accurate in laboratory and clinical studies.
Q2: When can I start testing?
You can test as early as 1 day after your missed period at any time of the day.
Q3: What should I do if the result is positive?
A positive result indicates pregnancy. You should consult your doctor to confirm and discuss next steps.
Q4: Does a faint line mean I am pregnant?
Yes, any visible line in the test area combined with a line in the control area is considered a positive result.
Q5: What factors can affect the test result?
Drugs containing hCG can cause false positives. Alcohol, birth control pills, and most common medications should not affect the result.
Q6: How should the test kits be stored?
The kits should be stored at room temperature in their sealed pouches until use.

Related Products