Hosted on MSN7d
Roche’s STI assay panels gain FDA 510(k) clearance and CLIA waiver
Tests for chlamydia and gonorrhoea (CT/NG) and chlamydia, gonorrhoea, and Mycoplasma genitalium (CT/NG/MG) are included in ...
FierceBiotech8d
Roche nets clearances for sexually transmitted infection tests at the point of care
Roche has obtained U.S. government green lights allowing its point-of-care testing system to be used to screen for multiple ...
Pharmabiz9d
US FDA grants 510(k) clearance and CLIA waiver to Roche’s cobas liat sexually transmitted infection multiplex assay panels
US FDA grants 510(k) clearance and CLIA waiver to Roche’s cobas liat sexually transmitted infection multiplex assay panels: Basel Thursday, January 23, 2025, 09:00 Hrs [IST] Roc ...
Pharm Exec9d
FDA Grants 510(k) Clearance to Roche’s Cobas Liat Molecular Test for Sexually Transmitted Infections
The cobas liat test aims to improve patient outcomes by offering rapid, accurate results in decentralized and community-based ...
BioWorld10d
Roche receives FDA approval for STI point-of-care tests
Roche AG secured U.S. FDA 510(k) clearance for its cobas liat sexually transmitted infection (STI) multiplex assay panels. The tests, which also received a Clinical Laboratory Improvement Amendments ...
World Bank6y
Tanzania: Using Cash to Encourage Young Adults to Abstain from Risky Sexual Behavior
Trichomonas vaginalis and Mycoplasma genitalium) at periodic testing rounds (every four months for one year). Anyone testing positive was offered free treatment, and all received counselling. The ...
PharmiWeb8d
Roche receives FDA clearance with CLIA waiver for…
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver ...