FDA.reportPublic FDA data

Multiple vasculitis-associated antibody IVD, kit, multiplex

Definition
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative screening for one or multiple antibodies associated with vasculitis in a clinical specimen, using a multiplex method. The assayed antibodies may include autoimmune antibodies directed at the glomerular basement membrane (GBM), anti-neutrophil cytoplamic antibodies to myeloperoxidase (ANCA MPO) and/or anti-neutrophil cytoplamic antibodies to proteinase-3 (PR3).
GUDID devices
6
Last updated
2019-04-02 04:13:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00845533000024AtheNA Multi-Lyte® AIV Plus Test SystemZEUS SCIENTIFIC, INC.A961012016-09-24
00847865000536BioPlex 2200BIO-RAD LABORATORIES, INC.66518502016-09-12
00847865002387BioPlex 2200BIO-RAD LABORATORIES, INC.SW4V22016-09-12
00847865002394BioPlex 2200BIO-RAD LABORATORIES, INC.SW4 V22016-09-12
00847865010955BioPlex 2200BIO-RAD LABORATORIES, INC.SW4.1 V12016-09-12
00847865011082BioPlex 2200BIO-RAD LABORATORIES, INC.SW4.1V12016-09-12