Home › Device types › GTZ
Antisera, All Groups, Streptococcus Spp.
FDA product code GTZ · Class 1 · Microbiology
127
Registered devices
39
Adverse events
3
Recalls
105
510(k) clearances
Devices with this code
PathoDx Extraction Reagent 3 — REMEL EUROPE LIMITEDImmuLex Streptococcus Type IX, 1,5 ml — Ssi Diagnostica A/SOxoid Reaction Cards — OXOID LIMITEDPATHODXTRA STREP GROUP C LATEX — OXOID LIMITEDBD BBL™ Streptocard™ Enzyme C Test Latex — BECTON, DICKINSON AND COMPANYProlex Streptococcal Grouping Reagent Latex Suspension Group F — PRO-LAB, INCORPORATEDImmuLex Streptococcus Type IV, 1,5 mL — Ssi Diagnostica A/SBD BBL™ Streptocard™ Acid Extraction Reagent — BECTON, DICKINSON AND COMPANYLatex Grouping Reagent F — OXOID LIMITEDBD BBL™ Streptocard™ Enzyme Test Latex D — BECTON, DICKINSON AND COMPANYBinaxNOW Streptococcus pneumoniae Antigen Card — Alere Scarborough, Inc.QuickVue — QUIDEL CORPORATIONN/A — HARDY DIAGNOSTICSImmuLex Streptococcus Type VIII, 1,5 mL — Ssi Diagnostica A/SProlex Mixing Sticks — PRO-LAB, INCORPORATEDBD BBL ™ Streptocard™ Enzyme Extraction — BECTON, DICKINSON AND COMPANYBD BBL™ Streptocard™ Acid Test Latex A — BECTON, DICKINSON AND COMPANYBinaxNOW Strep A Card — Alere Scarborough, Inc.PATHODXTRA STREP GROUP F LATEX — OXOID LIMITEDPATHODXTRA STREP GROUP D LATEX — OXOID LIMITEDBinaxNOW Strep A Control Swab Pack — Alere Scarborough, Inc.BD BBL™ Streptocard™ Acid Test Latex G — BECTON, DICKINSON AND COMPANYProlex Extraction Reagent Set — PRO-LAB, INCORPORATEDImmuLex Streptococcus Group F, 1.5 mL — Ssi Diagnostica A/S
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-08-20 | Cypress Medical Products LLC | Due to a classification error in our inventory management system, these medical devices were shipped to customers that did not have the requisite license to pur |
| 2009-04-06 | Binax, Inc. dba IMPD | Potential for false positive Strep A results. |
| 2004-06-11 | Abbott Laboratories HPD/ADD/GPRD | False Positive results may be obtained with the identified lots when using a negative patient sample or a negative control. |
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