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Chembio Diagnostic Systems

Last updated September 17, 2026

Information

Device	Model / Reference	Registries	Class	Status
Chembio DPP HIV 1/2 Assay	65-9500-0	FDA UDI	Class II	Active
DPP HIV-Syphilis	65-9502-0	FDA UDI	Class II	Active
Clearview Complete HIV 1/2	60-9523-0	FDA UDI	Class II	Unknown
Chembio SURE CHECK HIV 1/2 Assay	60-9507-0	FDA UDI	Class II	Active
ProciseDx Calibration Cartridge	5429	FDA UDI	Class II	Active
Chembio HIV 1/2 Stat-Pak Assay	60-9505-1	FDA UDI	Class II	Active
Procise ADL	5430	FDA UDI	Class II	Active
Procise IFX	5385	FDA UDI	Class II	Active
DPP Zika IgM System	65-9560-0	FDA UDI	Class II	Active
Chembio DPP HIV 1/2 Rapid Test Control Pack	60-9552-0	FDA UDI	Class II	Active
DPP Zika IgM Micro Reader	70-1064-0	FDA UDI	Class I	Active
Chembio HIV Reactive/Nonreactive Controls	60-9549-0	FDA UDI	Class II	Active
Clearview HIV Reactive/Nonreactive Controls	60-9546-0	FDA UDI	Class II	Active
Prevue(tm) Borrelia Burgdorferi Antibody Detection Assay	K981913	FDA 510(k)	Class II	Active
Hcg Stat Pak Ultra-Fast	K011550	FDA 510(k)	Class II	Active
Hcg Stat-Pak	K923925	FDA 510(k)	Class II	Active
Sure Check Ovulation Predictor	K010244	FDA 510(k)	Class I	Active
Sure Check Pregnancy Test	K011551	FDA 510(k)	Class II	Active
Sure Check Pregnancy Test	K961965	FDA 510(k)	Class II	Active
DPP Zika IgM System, DPP Zika IgM System Control Pack, and DPP Micro Reader	K200506	FDA 510(k)	Class II	Active

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