hCG Urine / Serum Pregnancy Cassette Device - Box of 25
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Description
The Pro Advantage hCG Pregnancy Cassette Device offers fast, reliable, and accurate pregnancy detection with a simple one-step process. Suitable for both urine and serum samples, this rapid test delivers highly sensitive results in just 3 minutes for urine and 5 minutes for serum, with >99% accuracy. It is CLIA Waived for urine testing and FDA 510(k) cleared, making it an essential diagnostic tool for healthcare professionals. The kit includes 25 individually packaged cassettes and droppers, ensuring convenience and reliability for every use.
Features
- Rapid Detection: Provides quick results in 3 minutes for urine and 5 minutes for serum samples.
- High Sensitivity: Detects hCG levels as low as 25 mIU/mL.
- Accuracy: Over 99% sensitivity and specificity ensure reliable results.
- One-Step Testing: Simple, one-step process for easy usage.
- CLIA Waived: Approved for urine testing, meeting regulatory standards for use in clinical settings.
- FDA Cleared: FDA 510(k) cleared, ensuring high-quality manufacturing and testing processes.
- Versatile Usage: Works for both urine and serum hCG detection, increasing flexibility for users.
Product Specifications
| Product Type: | hCG Pregnancy Cassette Device |
|---|---|
| Sample Types: | Urine and Serum |
| Sensitivity: | 25 mIU/mL |
| Accuracy: | >99% sensitivity and specificity |
| Test Time: | 3 minutes for urine, 5 minutes for serum |
|---|---|
| CLIA Waived: | Yes (for urine) |
| FDA 510(k) Clearance: | Yes |
| Quantity: | 25 cassettes per box |
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Frequently Asked Questions (FAQs)
The hCG Pregnancy Cassette Device is over 99% accurate in detecting pregnancy.
The device can detect hCG levels as low as 25 mIU/mL.
Results are available within 3 minutes for urine samples and 5 minutes for serum samples.
Yes, it is CLIA Waived for urine testing, making it suitable for clinical use.
Yes, this device has FDA 510(k) clearance, ensuring its quality and accuracy.