EXACT DIAGNOSTICS

Manufacturer · United States

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16registrations in Brazil

16currently valid

1registration holder

12device types

2023first registration

Registrations

Product	Device type	Class	Holder	Published	Status
Família Negative Control 80020690451	Combined parameters in one product - class IV	IV	BIO-RAD LABORATORIOS BRASIL LTDA	23/06/2025	Until 23/06/2035
Família Parvovirus B19 Run Control 80020690439	Parvovirus B19	III	BIO-RAD LABORATORIOS BRASIL LTDA	27/01/2025	Until 27/01/2035
HPV Genotype 18 Control 80020690437	Human papillomavirus (HPV)	III	BIO-RAD LABORATORIOS BRASIL LTDA	13/01/2025	Until 13/01/2035
HPV Genotype 68 Control 80020690438	Human papillomavirus (HPV)	III	BIO-RAD LABORATORIOS BRASIL LTDA	13/01/2025	Until 13/01/2035
Família Adenovirus Run Control 80020690436	Adenovirus	II	BIO-RAD LABORATORIOS BRASIL LTDA	23/12/2024	Valid
HPV Genotype 16 Control 80020690435	Human papillomavirus (HPV)	III	BIO-RAD LABORATORIOS BRASIL LTDA	29/10/2024	Until 29/10/2034
Família HCV Run Control 80020690433	Hepatitis C virus (HCV) nucleic acid	IV	BIO-RAD LABORATORIOS BRASIL LTDA	21/10/2024	Until 21/10/2034
Família HIV Run Control 80020690434	HIV-1 nucleic acid	IV	BIO-RAD LABORATORIOS BRASIL LTDA	21/10/2024	Until 21/10/2034
Família JCV Run Control 80020690432	JC virus (JCV) - John Cunningham virus	II	BIO-RAD LABORATORIOS BRASIL LTDA	07/10/2024	Valid
CT/NG Positive Run Control 80020690430	Combined parameters in one product - class IV	IV	BIO-RAD LABORATORIOS BRASIL LTDA	23/09/2024	Until 23/09/2034
HPV Negative Control 80020690431	Human papillomavirus (HPV)	III	BIO-RAD LABORATORIOS BRASIL LTDA	23/09/2024	Until 23/09/2034
Família HBV Run Control 80020690429	Hepatitis B virus (HBV) nucleic acid and antigen	IV	BIO-RAD LABORATORIOS BRASIL LTDA	05/08/2024	Until 05/08/2034
Família BKV Run Control 80020690427	BK polyomavirus	II	BIO-RAD LABORATORIOS BRASIL LTDA	22/07/2024	Valid
Família HHV-6 Run Control 80020690428	Herpesvirus (HHV-6 or 7)	II	BIO-RAD LABORATORIOS BRASIL LTDA	22/07/2024	Valid
Família EDX SARS-CoV-2, Flu, RSV 80020690423	Combined parameters - respiratory panel	III	BIO-RAD LABORATORIOS BRASIL LTDA	23/10/2023	Until 23/10/2033
Família RP Run Control 80020690422	Combined parameters in one product - class III	III	BIO-RAD LABORATORIOS BRASIL LTDA	09/10/2023	Until 09/10/2033