DIASORIN MOLECULAR LLC: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
Simplexa™ Adenovirus Molecular Control 10339840538	Adenovirus	II	DIASORIN LTDA	26/05/2022	Valid
Família Simplexa VZV Direct 10339840522	Herpesvirus (HHV-3) - varicella-zoster	III	DIASORIN LTDA	23/03/2020	Until 23/03/2030
Família Simplexa GBS Direct 10339840518	Streptococcus	III	DIASORIN LTDA	14/10/2019	Until 14/10/2029
Simplexa™ HSV 1 & 2 Direct 10339840513	Herpes simplex virus (HHV-2)	III	DIASORIN LTDA	02/09/2019	Until 02/09/2029
Simplexa Spectral Calibration Panel 10339840496	Buffers, diluents and other solutions for laboratory analysis	I	DIASORIN LTDA	08/04/2019	Valid
Simplexa Extraction & Amplification Control Set - RNA 10339840498	Buffers, diluents and other solutions for laboratory analysis	I	DIASORIN LTDA	08/04/2019	Valid
Simplexa Extraction & Amplification Control Set 10339840495	Polymerase chain reaction (PCR) control, non-specific	II	DIASORIN LTDA	25/03/2019	Valid
Simplexa System Calibration Panel 10259610152	Solution for performance testing of equipment components	I	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	03/11/2014	Valid
Bartonella IFA IgM 10259610147	Bartonella	II	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	10/03/2014	Valid
Bartonella IFA IgG 10259610148	Bartonella	II	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	10/03/2014	Valid
Simplexa Flu A/B & RSV Positive Control Pack 10259610142	Combined parameters - respiratory panel	III	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	29/10/2012	Until 29/10/2027
Simplexa Flu A/B & RSV DIRECT 10259610141	Combined parameters - respiratory panel	III	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	09/07/2012	Until 09/07/2027
Enterovirus primer pair 10259610140	Enterovirus	II	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	28/05/2012	Valid
BKV Primer Pair 10259610135	BK polyomavirus	II	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	06/02/2012	Valid
Histoplasma DxSelect™ 10259610132	Histoplasma capsulatum	II	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	30/01/2012	Valid
Adenovirus 3’ Hexon primer pair 10259610133	Adenovirus	II	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	30/01/2012	Valid
Simplexa CMV - Quantitation Standards 10259610129	Herpesvirus (HHV-5) - cytomegalovirus	IV	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	28/11/2011	Until 28/11/2026
Simplexa CMV 10259610130	Herpesvirus (HHV-5) - cytomegalovirus	IV	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	28/11/2011	Until 28/11/2026
Simplexa BKV 10259610127	BK polyomavirus	II	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	07/11/2011	Valid
Simplexa BKV - Quantitation Standards 10259610128	BK polyomavirus	II	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	07/11/2011	Valid
SIMPLEXA BORDETELLA 10259610122	Bordetella pertussis	III	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	17/10/2011	Until 17/10/2026
Bordetella parapertussis Primer Pair 10259610123	Bordetella pertussis	III	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	17/10/2011	Until 17/10/2026
Bordetella pertussis Primer Pair 10259610126	Bordetella pertussis	III	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	17/10/2011	Until 17/10/2026
REVERSE TRANSCRIPTASE 10259610118	Buffers, diluents and other solutions for laboratory analysis	I	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	01/08/2011	Valid
2.5X UNIVERSAL MASTER MIX 10259610119	Buffers, diluents and other solutions for laboratory analysis	I	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	01/08/2011	Valid
SIMPLEXA EXTRACTION & AMPLIFICATION CONTROL SET – RNA 10259610115	Buffers, diluents and other solutions for laboratory analysis	I	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	11/07/2011	Valid
SIMPLEXA EXTRACTION & AMPLIFICATION CONTROL SET 10259610113	Buffers, diluents and other solutions for laboratory analysis	I	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	31/05/2011	Valid
HERPESELECT 1 ELISA IgG 10259610104	Herpes simplex virus (HHV-1)	II	MEDIVAX INDÚSTRIA E COMÉRCIO LTDA	20/12/2010	Valid

DIASORIN MOLECULAR LLC

Brazilian registration holders

Device types

Registrations