HCG Early Result Pregnancy Test Strips | 10 mIU/mL | CLIA Waived | 25/Box

HCG Early Result Pregnancy Test Strips | 10 mIU/mL | CLIA Waived | 25/Box provide fast, qualitative urine-based pregnancy screening in an easy-to-use dip strip format. Designed for professional testing environments, these early result test strips detect human chorionic gonadotropin (hCG) in urine with a sensitivity of 10 mIU/mL and deliver visual results in approximately 3–5 minutes. Each box contains 25 individually packaged test strips, with 120 boxes per case for convenient clinical and high-volume purchasing. [page:3]

Product Information

Human chorionic gonadotropin (hCG) is a hormone produced shortly after conception and commonly detected in urine during pregnancy. This dip strip pregnancy test is a rapid chromatographic immunoassay designed for qualitative detection of hCG in urine to support early pregnancy screening. Its strip format allows direct specimen immersion and straightforward visual interpretation in professional point-of-care settings. [page:3]

Product Specifications

Key Features

• 10 mIU/mL sensitivity: Supports early qualitative detection of hCG in urine. [page:3]
• >99% accuracy: Designed for reliable pregnancy screening when used according to instructions. [page:3]
• Fast 3–5 minute results: Helps streamline testing workflow in professional settings. [page:3]
• Easy dip strip format: Supports simple specimen application with direct urine immersion. [page:3]
• Line-based visual results: Provides clear control and test line interpretation. [page:3]
• CLIA Waived: Suitable for qualifying waived testing environments. [page:3]
• FDA Cleared: Cleared for its intended professional use. [page:3]
• CPT Code 81025: Associated with urine pregnancy testing by visual color comparison. [page:3]
• 25 individually packaged strips: Convenient for routine professional use. [page:3]
• 120 boxes per case: Practical for larger volume purchasing and replenishment. [page:3]

Interpretation of Test Results

How Does It Work?

This dip strip pregnancy test detects human chorionic gonadotropin (hCG) in urine. The absorbent end of the strip is placed into the urine specimen according to the product instructions, allowing the sample to migrate through the test membrane. If hCG is present at or above the test threshold, a colored test line appears, while the control line confirms the test has functioned properly. 

How to Read Results

Negative (Not Pregnant): One colored line appears in the Control region only. No visible line appears in the Test region.

Positive (Pregnant): Two colored lines appear, one in the Control region and one in the Test region. The color intensity of the test line may vary depending on the hCG concentration in the specimen. 

Invalid: If no control line appears, the result is invalid and the test should be repeated with a new test device. 

Frequently Asked Questions

1. What type of sample is used with this test?
This pregnancy test is designed for urine specimens and uses a dip strip format for qualitative screening. 

2. How sensitive is this pregnancy test?
This product has a sensitivity of 10 mIU/mL for early hCG detection in urine. 

3. How long does it take to get results?
Results are typically available in approximately 3–5 minutes when the test is used as directed. 

4. Is this product CLIA waived?
Yes. This product is listed as CLIA Waived and is also shown as FDA Cleared for its intended use. [

5. How many tests are included?
Each box contains 25 individually packaged test strips, and each case contains 120 boxes.