FDA.reportPublic FDA data

Beta-haemolytic Group A Streptococcus nucleic acid 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 nucleic acid from Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.
GUDID devices
12
Last updated
2026-08-01 06:05:08

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
20816101029079LIAISON NES® Group A Strep Control Swab KitDIASORIN MOLECULAR LLCNES28602026-07-23
01220000260450NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Strep A Positive Control 2025-09-10
01220000260467NATtrol™ZEPTOMETRIX CORPORATIONNATtrol™ Strep A Negative Control 2025-09-10
15420045511552Panther Fusion®Hologic, Inc.LBLD, GAS PLASMID (UNASSAYED CONTROL)2024-04-05
10811877010200Alere i Strep A 2 Control Swab KitAlere Scarborough, Inc.734-0802018-06-28
10811877010583ID NOW Strep A 2 Control Swab KitAlere Scarborough, Inc.734-0802018-10-29
10811877010866Alere™ i Strep A Control Swab KitAlere Scarborough, Inc.733-0802016-09-03
70845357041493QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82192020-04-30
70845357042735QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.82322020-04-30
00840733101328illumigene Group A Streptococcus External Control KitMERIDIAN BIOSCIENCE, INC.2799102016-09-23
20816101025576Simplexa™ Group A Strep Positive Control PackDIASORIN MOLECULAR LLCMOL28602016-09-22
00875197005646cobas® Strep A Quality Control Kit for use on the cobas® Liat® SystemRoche Molecular Systems, Inc.074026781902016-09-24