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No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
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2 00855574005421 STS25 Strep A, Immunochromatographic GTY Antigens, All Groups, Streptococcus Spp. 1 Poly stat
3 00855574005414 HP20 H. Pylori, Immunochromatographic LYR Helicobacter Pylori 1 Poly stat
4 00855574005391 HCG-POCU Qualitative HCG Control, Urine JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Poly stat
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6 00855574005377 HCG-POC Qualitative HCG Control JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Poly stat
7 00816917022925 FLU25 Flu A & B, Immunochromatographic, 25 Test Kit GNX Antigens, Cf (Including Cf Control), Influenza Virus A, B, C 1 Poly stat
8 00816917021546 MN20 Mono, Immunochromatographic KTN System, Test, Infectious Mononucleosis 2 Poly stat
9 00855574005360 ANA-CAL Anti Nuclear Antibody, Calibrator, PolyTiter DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control 2 PolyTiter
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
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2 00848838063701 R246003 Xpect Flu A&B Control 20Swab/SET Remel REMEL, INC.
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4 00742860100215 1005 1005 OSOM Ultra Flu A&B Controls 5 Test OSOM Ultra Flu A&B Controls 5 Test SEKISUI DIAGNOSTICS, LLC
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7 00722066003343 FLUab-19C15 FLUab-19C15 Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitat Rapid Response Influenza A&B Test Cassettes - 15 tests/ kit are for the qualitative detection of Influenza A and B Virus Antigens in nasal specimens. Rapid Response BTNX INC
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9 00382902560746 256074 256074 BD Veritor™ Plus CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ Sys BD Veritor™ Plus CLIA-Waived Combo Pack Contains: 2xBD Veritor ™ System for Rapid Detection of Flu A+B, CLIA-Wavied Kits (Cat. No. 256045) 1xBD Veritor ™ Plus Analyzer (Cat. No. 256066) BD Veritor™ Plus CLIA-Waived Combo Pack BECTON, DICKINSON AND COMPANY
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21 20612479226795 181-36026 Influenza A & B Test NASOPHARYNGEAL WASH/ASPIRATE KIT McKesson MCKESSON MEDICAL-SURGICAL INC.
22 20612479225118 181-36025 Influenza A & B Test McKesson MCKESSON MEDICAL-SURGICAL INC.
23 20608337000065 1001-0320 OraSure Quick Flu 22-Count Flu A + B Kit ORASURE TECHNOLOGIES, INC.
24 10743816001508 BSP-510-25-02 BSP-510-25-02 Status Flu A+B; 25 Test Kit Status Flu A+B card PRINCETON BIOMEDITECH CORPORATION
25 10743816001478 BSP-510-25-01 BSP-510-25-01 BioSign Flu A+B; 25 Test Kit BioSign Flu A+B card PRINCETON BIOMEDITECH CORPORATION
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