Multiple-genus respiratory virus antigen IVD, control

Definition
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of antigens from multiple virus genera associated with respiratory diseases in a clinical specimen. Viruses intended to be detected may include respiratory syncytial virus (RSV), influenza viruses, parainfluenza viruses, human metapneumovirus, coronaviruses, enteroviruses, rhinoviruses and/or adenoviruses.
GUDID devices
11
Last updated
2026-07-17 21:59:47

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00742860000072OSOM Flu SARS-CoV-2 Combo Control KitSekisui Diagnostics, LLC10792024-12-16
00850010224459CareSuperb COVID-19/Flu A&B Antigen Combo External ControlAccess Bio Inc.SCNM-001712026-06-08
00816862027303WELLlife™WONDFO USA CO., LTD.WCOV-CON-52026-06-01
00840733101557statID Pro COVID-19/Flu External ControlsMERIDIAN BIOSCIENCE, INC.7830102026-04-10
00875197007329cobas® Respiratory flex Control KitRoche Molecular Systems, Inc.096237281902026-02-24
30014613340768QuickVue™WONDFO USA CO., LTD.205192025-10-31
B379RCFPCK101COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (10 sets)INBIOS INTERNATIONAL, INCRCFP-CK102025-10-06
B379RCFPCK201COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (20 sets)INBIOS INTERNATIONAL, INCRCFP-CK202025-10-06
B379RCFPCK21COVID/Flu A&B RespiraDX Rapid Test Control Kit Box (1 set)INBIOS INTERNATIONAL, INCRCFP-CK22025-10-06
00811877012108BinaxNOW COVID-19/Flu A&B ControlsAlere Scarborough, Inc.20002055 2025-01-30
05032384503070IMAGEN RESPIRATORY SCREEN POS CON SLIDEOXOID LIMITEDS612130-22024-07-03