Product code QID— Microbiology
OraQuick Ebola Rapid Antigen Test
- Classification name
- Device To Detect Antigens Of Biothreat Microbial Agents In Human Clinical Specimens
- Device class
- Class 2
- Regulation
- 21 CFR 866.4002
- Advisory panel
- Microbiology
- Total cleared
- 1
- First cleared
- Most recent
FDA classification definition
“A device to detect antigens of biothreat microbial agents in human clinical specimens is identified as an in vitro diagnostic device intended for the detection of antigens of microbial agents in specimens collected from patients with signs and symptoms of infection with biothreat microbial agents and who have been exposed to these agents or are suspected or at risk of exposure. Devices to detect antigens of biothreat microbial agents in human clinical specimens may be used for cadaver testing if the cadaver constitutes a source of human-to-human transmission and if testing is performed to prevent human disease.”
Market context for product code QID
FDA has cleared device under product code QID, all in 2019, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code QID
Recent clearances under product code QID
Data sourced from openFDA. This site is unofficial and independent of the FDA.