NOVA BIOMEDICAL CORPORATION: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
Stat Profile Prime Plus® MicroSensor Card™ with COOX 81175310121	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	12/01/2026	Until 12/01/2036
Stat Profile Prime Plus® MicroSensor Card™ 81175310122	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	12/01/2026	Until 12/01/2036
Stat Profile Prime Plus® MicroSensor Card™ BUN, Creatinine 81175310123	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	12/01/2026	Until 12/01/2036
Prime Sensor Card CCS Comp 81175310124	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	12/01/2026	Until 12/01/2036
Stat Profile Prime® Plus Calibrator Cartridge 81175310113	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	05/01/2026	Until 05/01/2036
Stat Profile Prime® Plus Calibrator Cartridge With Creatinine 81175310114	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	05/01/2026	Until 05/01/2036
Stat Profile® Prime Ampuled Control ABG/CCS 81175310115	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	05/01/2026	Until 05/01/2036
Stat Profile Prime® Calibrator Cartridge CCS Comp 81175310116	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	05/01/2026	Until 05/01/2036
Stat Profile® Prime Auto QC Cartridge CCS 81175310117	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	05/01/2026	Until 05/01/2036
Stat Profile Prime Plus® Blood Gas, CO-Oximeter, Chemistry Controls Auto-Cartridge with Creatinine 81175310118	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	05/01/2026	Until 05/01/2036
Stat Profile Prime Plus® Blood Gas/CO-Oximeter Controls 1, 2, and 3 81175310119	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	05/01/2026	Until 05/01/2036
Stat Profile Prime Plus® Blood Gas, CO-Oximeter, Chemistry Controls Auto-Cartridge 81175310120	Combined parameters in one product - class III	III	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	05/01/2026	Until 05/01/2036
StatStrip GLU - Tiras de teste 81175310110	Glucose - point-of-care testing (professional)	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	26/06/2023	Valid
Família de controles StatStrip GLU KET 81175310111	Glucose and ketone bodies - point-of-care testing (professional)	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	26/06/2023	Valid
Família de medidores StatStrip GLU KET 81175310112	Glucose and ketone bodies instrument - point-of-care testing (professional)	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	26/06/2023	Valid
Kit de linearidade StatStrip GLU KET 81175310109	Glucose and ketone bodies - point-of-care testing (professional)	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	19/06/2023	Valid
StatStrip KET - Tiras de teste 81175310108	Ketones	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	03/04/2023	Valid
Nova Max Pro Creat eGFR Meter 81175310106	Analyzer for general chemistry, hormones, drugs or proteins	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	06/10/2022	Valid
Nova Max Pro Creat eGFR Linearity e Controls 81175310107	Creatinine	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	06/10/2022	Valid
Nova Max Pro Creat eGFR Test Strips 81175310105	Creatinine	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	29/09/2022	Valid
Allegro® Lipids Control Solution 81175310104	Combined parameters in one product - class II	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	03/03/2022	Valid
STATSTRIP LAC/HB/HCT METER 81175310103	Combined parameters in one product - class II	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	23/09/2021	Valid
StatStrip® Lactate Control Solution Level 2 81175310098	Lactate	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	08/07/2019	Valid
StatStrip® Lactate Test Strips 81175310099	Lactate	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	08/07/2019	Valid
StatStrip® Lactate Linearity Kit, 4 Levels 81175310101	Lactate	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	08/07/2019	Valid
StatStrip® Lactate Control Solution Level 1 81175310102	Lactate	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	08/07/2019	Valid
Allegro Lipids Control Solution Level 1 81175310094	Combined parameters in one product - class II	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	06/05/2019	Valid
Allegro Lipids Control Solution Level 2 81175310095	Combined parameters in one product - class II	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	06/05/2019	Valid
Allegro® Lipids Test Cartridge 81175310096	Combined parameters in one product - class II	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	06/05/2019	Valid
Allegro® UACR Test Cartridge 81175310097	Combined parameters in one product - class II	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	06/05/2019	Valid
StatStrip® Hemoglobin and Hematocrit Meter 81175310089	Analyzer for general chemistry, hormones, drugs or proteins	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	22/04/2019	Valid
StatStrip® Hemoglobin and Hematocrit Control Solution Level 1 81175310090	Hemoglobin	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	22/04/2019	Valid
StatStrip® Hemoglobin and Hematocrit Linearity Solution Level 1, 2 and 3 81175310091	Hemoglobin	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	22/04/2019	Valid
StatStrip® Hemoglobin and Hematocrit Test Strip 81175310092	Hemoglobin	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	22/04/2019	Valid
StatStrip® Hemoglobin and Hematocrit Control Solution Level 2 81175310093	Hemoglobin	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	22/04/2019	Valid
Allegro® HbA1c Control Solution Level 1 81175310083	Glycated hemoglobin (HbA1c)	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	03/12/2018	Valid
Allegro® HbA1c Control Solution Level 2 81175310084	Glycated hemoglobin (HbA1c)	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	03/12/2018	Valid
Allegro® HbA1c Test Cartridge 81175310085	Glycated hemoglobin (HbA1c)	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	03/12/2018	Valid
Allegro UACR Control Solution Level 1 81175310086	Combined parameters in one product - class II	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	03/12/2018	Valid
Allegro UACR Control Solution Level 2 81175310087	Combined parameters in one product - class II	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	03/12/2018	Valid
ALLEGRO® CAPILLARY BLOOD ANALYZER 81175310088	Analyzer for general chemistry, hormones, drugs or proteins	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	03/12/2018	Valid
Analisador Stat Profile Prime® Plus 81175310076	Analyzer for blood gases, ions or pH	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	07/05/2018	Valid
Stat Profile Prime Plus® Chemistry Controls 4 and 5 81175310073	Combined parameters in one product - class II	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	30/04/2018	Valid
Prime Sensor Card ES Basic 81175310069	Electrolytes	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	14/08/2017	Valid
Prime Sensor Card ES Comp 81175310070	Electrolytes	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	14/08/2017	Valid
Prime Ampuled Controls ES 81175310071	Electrolytes	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	14/08/2017	Valid
Stat Profile Prime® Calibrator Cartridge ES Comp 81175310072	Electrolytes	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	14/08/2017	Valid
Família Stat Profile® Prime ES 81175310068	Analyzer for blood gases, ions or pH	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	07/08/2017	Valid
Stat Profile Prime® Calibrator Cartridge ES Basic 81175310062	Multi-analyte calibrators and standards, one or more concentrations - class II	II	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	05/06/2017	Valid
Prime ES Diluent 81175310061	Buffers, diluents and other solutions for laboratory analysis	I	NOVA BIOMEDICAL DIAGNÓSTICOS MÉDICOS E BIOTECNOLOGIA LTDA	29/05/2017	Valid

NOVA BIOMEDICAL CORPORATION

Brazilian registration holders

Device types

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