FDA.reportPublic FDA data

Beta-haemolytic Streptococcus serological grouping IVD, reagent

Definition
A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay used to determine the serological group (or Lancefield group) of beta-haemolytic streptococci isolated from a clinical specimen by culture.
GUDID devices
48
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
05032384013043Latex Grouping Reagent AOXOID LIMITEDDR0586G2024-06-19
05032384013050Latex Grouping Reagent BOXOID LIMITEDDR0587G2024-06-19
05032384013067Latex Grouping Reagent COXOID LIMITEDDR0588G2024-06-19
05032384013074Latex Grouping Reagent DOXOID LIMITEDDR0589G2024-06-19
05032384013081Latex Grouping Reagent FOXOID LIMITEDDR0590G2024-06-19
05032384013098Latex Grouping Reagent GOXOID LIMITEDDR0591G2024-06-19
05032384519569PathoDxtra Extraction ReagentsOXOID LIMITEDDR0709M2024-06-19
05032384519576PATHODXTRA STREP GROUPING REAGENT SETOXOID LIMITEDDR0710M2024-06-19
05032384519835PATHODXTRA STREP GROUP A LATEXOXOID LIMITEDDR0701G2024-06-19
05032384519842PATHODXTRA STREP GROUP B LATEXOXOID LIMITEDDR0702G2024-06-19
05032384519859PATHODXTRA STREP GROUP C LATEXOXOID LIMITEDDR0703G2024-06-19
05032384519866PATHODXTRA STREP GROUP D LATEXOXOID LIMITEDDR0704G2024-06-19
05032384519873PATHODXTRA STREP GROUP F LATEXOXOID LIMITEDDR0705G2024-06-19
05032384519880PATHODXTRA STREP GROUP G LATEXOXOID LIMITEDDR0706G2024-06-19
05032384013111EXTRACTION ENZYMEOXOID LIMITEDDR0593G2022-12-04
05056080501246PathoDx Strep A Grouping LatexREMEL EUROPE LIMITEDR620302021-07-21
05056080501253PathoDx Strep B Grouping LatexREMEL EUROPE LIMITEDR620312021-07-21
05056080501260PathoDx Strep C Grouping LatexREMEL EUROPE LIMITEDR620322021-07-21
05056080501277PathoDx Strep F Grouping LatexREMEL EUROPE LIMITEDR620342021-07-21
05056080501284PathoDx Strep G Grouping LatexREMEL EUROPE LIMITEDR620352021-07-21
05056080501307PathoDx Extraction Reagent 1 (7ml)REMEL EUROPE LIMITEDR620502021-07-21
05056080501314PathoDx Extraction Reagent 1 (14ml)REMEL EUROPE LIMITEDR620522021-07-21
05056080501321PathoDx Extraction Reagent 2 (7ml)REMEL EUROPE LIMITEDR620552021-07-21
05056080501338PathoDx Extraction Reagent 2 (14ml)REMEL EUROPE LIMITEDR620572021-07-21
05056080501345PathoDx Extraction Reagent 3REMEL EUROPE LIMITEDR620602021-07-21
05056080501352PathoDx Strep Grouping Universal Kit (60 test)REMEL EUROPE LIMITEDR620762021-07-21
05056080501369PathoDx Strep Grouping Universal Kit (120 test)REMEL EUROPE LIMITEDR621502021-07-21
05056080501406Streptex Latex AREMEL EUROPE LIMITEDR309506012021-07-21
05056080501413Streptex Latex BREMEL EUROPE LIMITEDR309507012021-07-21
05056080501420Streptex Latex CREMEL EUROPE LIMITEDR309508012021-07-21
05056080501437Streptex Latex DREMEL EUROPE LIMITEDR309509012021-07-21
05056080501444Streptex Latex FREMEL EUROPE LIMITEDR309511012021-07-21
05056080501451Streptex Latex GREMEL EUROPE LIMITEDR309512012021-07-21
05056080501475Streptex Extraction EnzymeREMEL EUROPE LIMITEDR309510012021-07-21
05056080501482Streptex Acid Extraction KitREMEL EUROPE LIMITEDR309513012021-07-21
00819398027854StrepPRO™HARDY DIAGNOSTICSPL031HD2020-09-02
00819398027861StrepPRO™HARDY DIAGNOSTICSPL032HD2020-09-02
00819398027878StrepPRO™HARDY DIAGNOSTICSPL033HD2020-09-02
00819398027885StrepPRO™HARDY DIAGNOSTICSPL034HD2020-09-02
00819398027892StrepPRO™HARDY DIAGNOSTICSPL035HD2020-09-02
00819398027908StrepPRO™HARDY DIAGNOSTICSPL036HD2020-09-02
00819398027915StrepPRO™HARDY DIAGNOSTICSPL037HD2020-09-02
00819398027922StrepPRO™HARDY DIAGNOSTICSPL038HD2020-09-02
00819398027939StrepPRO™HARDY DIAGNOSTICSPL039HD2020-09-02
00819398027946StrepPRO™HARDY DIAGNOSTICSPL040HD2020-09-02
00819398027960N/AHARDY DIAGNOSTICSPL091HD2020-09-02
00819398027977N/AHARDY DIAGNOSTICSPL092HD2020-09-02
00819398027984StrepPRO™HARDY DIAGNOSTICSPL030HD2020-09-02