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
Prolex Extraction Reagent Set — PRO-LAB, INCORPORATEDProlex Streptococcal Xtra Select Kit — PRO-LAB, INCORPORATEDBD Directigen™ Group B Strep Test — BECTON, DICKINSON AND COMPANYPathoDx Strep G Grouping Latex — REMEL EUROPE LIMITEDStrepPRO™ — HARDY DIAGNOSTICSPhadebact Strep F Test — Mkl Diagnostics ABOxoid Streptococcal Grouping Kit — OXOID LIMITEDImmuLex Streptococcus Type Ib, 1,5 mL — Ssi Diagnostica A/SProlex Streptococcal Grouping Reagent Extraction Reagent 3 (2 x 8 ml) — PRO-LAB, INCORPORATEDBD BBL™ Streptocard™ Acid Positive Control — BECTON, DICKINSON AND COMPANYBD BBL™ Streptocard™ Enzyme Test Latex B — BECTON, DICKINSON AND COMPANYBD BBL™ Streptocard™ Acid Test Latex C — BECTON, DICKINSON AND COMPANYN/A — HARDY DIAGNOSTICSProlex Streptococcal Grouping Reagent Latex Suspension Group F — PRO-LAB, INCORPORATEDPATHODXTRA DISPOSABLE CARDS — OXOID LIMITEDStrepPRO™ — HARDY DIAGNOSTICSStrepPRO™ — HARDY DIAGNOSTICSBD BBL™ Streptocard™ Acid Test Latex G — BECTON, DICKINSON AND COMPANYLatex Grouping Reagent G — OXOID LIMITEDImmuLex Streptococcus Group D, 1.5 mL — Ssi Diagnostica A/SBD BBL™ Streptocard™ Enzyme Test Latex D — BECTON, DICKINSON AND COMPANYProlex Mixing Sticks — PRO-LAB, INCORPORATEDPathoDxtra Polyvalent Positive Control — OXOID LIMITEDBD BBL™ Streptocard™ Enzyme C Test Latex — BECTON, DICKINSON AND COMPANY
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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