About this document
Wholepower Pregnancy Test CLIA Waiver by Alvaro Sanchez is a document available to read on EtoBox.
The FDA has categorized three pregnancy test systems from Wholepower Biotech Co., Ltd. as waived under CLIA. The tests - WHOLEPOWER Pregnancy Rapid Test Cassette, Strip, and Midstream - detect human chorionic gonadotropin (hCG) in urine through visual color comparison. Any changes to the test systems or instructions must be submitted to the FDA for evaluation. The waived categorization is effective as of the date of notification and will be reported in the FDA
- Author
- Alvaro Sanchez
- Language
- EN