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Antigens, All Groups, Streptococcus Spp.
FDA product code GTY · Class 1 · Microbiology
183
Registered devices
389
Adverse events
20
Recalls
44
510(k) clearances
Devices with this code
S. pneumoniae reference strain 7B — Ssi Diagnostica A/SQuickVue — QUIDEL CORPORATIONS. pneumoniae reference strain 2 — Ssi Diagnostica A/SS. pneumoniae reference strain 9A — Ssi Diagnostica A/SSignify® — Alere San Diego, Inc.S. pneumoniae reference strain 6C — Ssi Diagnostica A/SS. pneumoniae reference strain 10A — Ssi Diagnostica A/SS. pneumoniae reference strain 33D — Ssi Diagnostica A/SCARDINAL HEALTH — Cardinal Health 200, LLCStreptococcus reference strain group B — Ssi Diagnostica A/SS. pneumoniae reference strain 24A — Ssi Diagnostica A/SOSOM Ultra Strep A 50 Test Kit — Sekisui Diagnostics, LLCS. pneumoniae reference strain 36 — Ssi Diagnostica A/SMcKesson — MCKESSON MEDICAL-SURGICAL INC.S. pneumoniae reference strain 20 — Ssi Diagnostica A/SWampole ColorCard® Streptozyme® — ALERE NORTH AMERICA, LLCS. pneumoniae reference strain 15F — Ssi Diagnostica A/SGroup B Streptococcus Detection Kit(Immunochromatography) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Streptococcus reference strain group C — Ssi Diagnostica A/SS. pneumoniae reference strain 9V — Ssi Diagnostica A/SQuickVue — QUIDEL CORPORATIONOSOM Ultra Strep A 5 Test Kit — Sekisui Diagnostics, LLCS. pneumoniae reference strain 12B — Ssi Diagnostica A/SQuickVue — QUIDEL CORPORATION
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-06 | Quidel Corporation | Product has the potential for false positive results |
| 2025-12-19 | Altruan GmbH | Product not cleared by the FDA. |
| 2025-12-19 | Altruan GmbH | Product not cleared by the FDA. |
| 2025-12-19 | Altruan GmbH | Product not cleared by the FDA. |
| 2025-07-30 | Mckesson Medical-Surgical Inc. Corporate Office | Due to a classification error in the inventory management system, specific medical devices were shipped to customers that did not have the requisite license to |
| 2025-06-17 | Quidel Corporation | Dipstick strep A test has potential for false positive results. |
| 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 |
| 2024-04-22 | Wondfo USA Co Ltd | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distributi |
| 2024-04-22 | Wondfo USA Co Ltd | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distributi |
| 2024-04-22 | Wondfo USA Co Ltd | Wondfo USA has identified unauthorized distribution of the Preview Strep A Test Kit. Unauthorized distribution of this device would include sales and distributi |
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