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Establishment Registration & Device Listing
WebFDA Clia Waived 510 (k) # K123703. CE Marked. FDA Cleared. OTC (Over-The-Counter) Non-prescription approved by the FDA. Test Results in 5 Minutes. Cassette Format with Pipette. 25 mIU/ml Sensitivity. One Step Rapid Test (Cassette) is an in vitro diagnostic visual qualitative immunochromatographic assay. Rapid test for the determination of … WebThe Healgen hCG One Step Pregnancy Test (cassette and strip) is a rapid sandwich immunoassay device designed for the qualitative determination of human chorionic gonadotropin (hCG) concentration in human urine samples, as an aid in the early detection of pregnancy. The test is available in three formats: strip, cassette, Both refresh water toowoomba
Establishment Registration & Device Listing - Food and Drug …
WebRegistration Yr. HEALGEN SCIENTIFIC LLC. 9. TX/USA. 3009238284. 2024. kit, test, pregnancy, hcg, over the counter - Healgen Scientific LLC; PreScreen Plus Pregnancy One Step Rapid Test Cassette; PreScreen Plus Pregnancy One Step Rapid Test Midstream; PreScreen Plus Pregnancy One Step Rapid Test Strip. 10. Specification Developer; … Webserum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy. The One Step+ hCG Urine Cassette Test is a rapid test that qualitatively detects the presence of hCG in urine specimen at the sensitivity of 25 mIU/mL. The test utilizes WebWhat is Healgen COVID-19 Rapid Antigen Self Test Kit? - CE Marked: For Self-Testing - Evaluated and validated by the UK’s MHRA - Easy to Use: No special equipment … refresh water phone number