MAUDE Adverse Event Report | 合法醫療器材資訊網

The Alere™ TestPack +Plus hCG Urine Test is a rapid immunoassay for the qualitative detection of human Chorionic Gonadotrophin (hCG) in urine or serum for early detection of pregnancy. ... which only incorporate a procedural control, TestPack has built-in Read More

The Alere™ hCG Cassette (25 mIU/mL) is a one-step test for the early detection of human chorionic gonadotropin (hCG), a hormone produced during pregnancy. ... Fast. Single-step test provides positive results in as little as 3 minutes. ... none. False. acc Read More

The presence and rapid rise of hCG levels in urine make it an excellent marker for the diagnosis of pregnancy. With proven accuracy of >99%, Alere™ hCG Easy​ ... Read More

2014年4月8日 — Though the 11 most popular hospital urine pregnancy tests perform well in ... tests become significantly more likely to produce false-negative results ... and the Alere—were not significantly affected by hCG beta core fragment. Read More

Caller reported false negative urine hcg results with qupid pregnancy test vs serum quantitative test. Pt was late with her period and did three home pregnancy ... Read More

Caller reported potential false negative hcg results on the innovacon hcg urine vs two positive unspecified home pregnancy tests on one pt. The pt returned the ... Read More

pregnancy, as it should contain the highest concentration of hCG5. ... False positive and false negative pregnancy tests have been observed in patients with ... For further information, please contact your distributor, or call Alere Technical. Read More

This test provides a presumptive diagnosis for pregnancy. A confirmed ... and TSH (1,000 μIU/mL) to negative (0 mIU/mL hCG) and positive (25 mIU/ ... 2011 Alere. ... False negative results may occur when the levels of hCG are below the. Read More