Pregnancy test IH-HYW-0002

hCGurineimmunochromatographic

Product Overview
The HIGHTOP-hCG rapid test is an immunochromatographic lateral-flow assay for the early qualitative detection of human chorionic gonadotropin (hCG) in urine. It is intended for in vitro diagnostic use and provides a visual indication of pregnancy via control and test lines.

Packaging / Quantities

• 1 x 1 T
• 1 x 25 T

Product Details
Product Name: hCG Pregnancy Test Cassette
Catalog No.: IH-HYW-0002
Commercial designation: HIGHTOP-hCG rapid test
Certification: FDA
Species characteristics: Human
Detection principle: Immunochromatographic (chromatographic immunoassay)
Specificity: Detects human chorionic gonadotropin (hCG)
Sample type: Urine
Application: Immediate in vitro qualitative detection of hCG as an indicator of pregnancy
Storage: Store at 4°C
Operating temperature: 4–30°C
Transportation condition: Room temperature
Cut-off sensitivity: 10 mIU/mL and 25 mIU/mL

Technical Specifications

• Test format: Cassette, lateral-flow
• Readout: Visual (control and test lines)
• Intended use: Early pregnancy screening
• Result type: Qualitative
• Available pack sizes: 1 x 1 T; 1 x 25 T

Storage and Handling
Store kits at 4°C. Do not freeze. Protect from direct sunlight and excessive humidity. Use components before the stated expiry date and allow test to reach operating temperature (4–30°C) before use.

Intended Use / Notes
For professional in vitro diagnostic screening of hCG in urine. Positive results indicate the presence of hCG and should be confirmed by a laboratory assay as required. This device is not intended for quantitative measurement or monitoring of therapy.