B350GSD051600NC0 ++B350GSD051600NCJ7 RPR Non-Reactive Control Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf C UNKNOWN Piyasada GSD05-1600-NC 2026-06-26T03:57:27.536Z B350GSD051600PC0 ++B350GSD051600PCJD RPR Reactive Control Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf C UNKNOWN Piyasada GSD05-1600-PC 2026-06-26T03:57:27.115Z B350003000 ++B35000300AY ThunderBolt EIA Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf A UNKNOWN Piyasada 00300 2026-06-16T00:28:49.117Z B35000300CL0 ++B35000300CLHZ ThunderBolt EIA (CLIA) Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf A UNKNOWN Piyasada 00300-CL 2026-06-16T00:28:49.092Z B350003500 ++B35000350BF HAILSTORM Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf A UNKNOWN AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) Piyasada 00350 2026-06-16T00:28:49.064Z B350004000 B-B350004000 AIX1000 Analyzer Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Genel UNKNOWN Piyasada 00400 2026-06-16T00:28:49.036Z B350005000 ++B35000500BA Bolt Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf A UNKNOWN Piyasada 00500 2026-06-16T00:28:49.017Z B35000500CL0 ++B35000500CLJP Bolt (CLIA) Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Sınıf A UNKNOWN Piyasada 00500-CL 2026-06-16T00:28:49.000Z B350GSD0116000 B-B350GSD0116000 Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Genel UNKNOWN Piyasada GSD01-1600 2026-06-16T00:28:48.978Z B350GSD0116005C0 B-B350GSD0116005C0 Gold Standard Diagnostics Rapid Plasma Reagin (RPR) Test System-5C Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Genel UNKNOWN Piyasada GSD01-1600-5C 2026-06-16T00:28:48.955Z B350GSD1600WCASE0 B-B350GSD1600WCASE0 Microtiterplates Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Genel UNKNOWN Piyasada GSD-1600-W-CASE 2026-06-16T00:28:48.938Z B350GSD341600R0 B-B350GSD341600R0 Gold Standard Diagnostics RPR Reagent Pack Gold Standard Diagnostics, LLC US-MF-000027142 Emergo Europe B.V. NL-AR-000000116 IVD Genel UNKNOWN Piyasada GSD34-1600-R 2026-06-16T00:28:48.920Z