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Antigens, All Groups, Streptococcus Spp.
FDA product code GTY · Class 1 · Microbiology
183
Registered devices
370
Adverse events
20
Recalls
44
510(k) clearances
Devices with this code
S. pneumoniae reference strain 2 — Ssi Diagnostica A/SS. pneumoniae reference strain 4 — Ssi Diagnostica A/SStreptococcus reference strain group C — Ssi Diagnostica A/SS. pneumoniae reference strain 15A — Ssi Diagnostica A/SMcKesson — MCKESSON MEDICAL-SURGICAL INC.PRO ADVANTAGE — NATIONAL DISTRIBUTION & CONTRACTING, INC.Sofia — QUIDEL CORPORATIONStreptococcus reference strain group B type IX — Ssi Diagnostica A/SS. pneumoniae reference strain 34 — Ssi Diagnostica A/SGroup B Streptococcus Detection Kit(Immunochromatography) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.Sofia — QUIDEL CORPORATIONSofia — QUIDEL CORPORATIONStreptococcus reference strain group B type IV — Ssi Diagnostica A/SGroup B Streptococcus Detection Kit(Immunochromatography) — Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.S. pneumoniae reference strain 33D — Ssi Diagnostica A/SStrepAim — GERMAINE LABORATORIES, INCHenry Schein — HENRY SCHEIN, INC.S. pneumoniae reference strain 33C — Ssi Diagnostica A/SS. pneumoniae reference strain 28F — Ssi Diagnostica A/SS. pneumoniae reference strain 5 — Ssi Diagnostica A/SSTREPAIM — GERMAINE LABORATORIES, INCS. pneumoniae reference strain 10A — Ssi Diagnostica A/SHenry Schein — HENRY SCHEIN, INC.S. pneumoniae reference strain 15C — Ssi Diagnostica A/S
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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