MICROGENICS CORPORATION: Brazil (ANVISA) registrations and registration holders

Product	Device type	Class	Holder	Published	Status
Família Mycophenolic Acid 80254180480	Mycophenolic acid	III	PHADIA DIAGNOSTICOS LTDA	22/04/2025	Until 22/04/2035
DRI Digoxin Assay 80254180467	Digoxin	III	PHADIA DIAGNOSTICOS LTDA	02/09/2024	Until 02/09/2034
Família QMS Everolimus 80254180465	Everolimus	III	PHADIA DIAGNOSTICOS LTDA	25/03/2024	Until 25/03/2034
Família CEDIA Cyclosporine PLUS 80254180463	Cyclosporine	III	PHADIA DIAGNOSTICOS LTDA	04/03/2024	Until 04/03/2034
Família QMS Tacrolimus 80254180462	Tacrolimus	III	PHADIA DIAGNOSTICOS LTDA	02/01/2024	Until 02/01/2034
CEDIA Phenytoin II Assay 80254180459	Phenytoin	III	PHADIA DIAGNOSTICOS LTDA	03/07/2023	Until 03/07/2033
CEDIA Phenobarbital II Assay 80254180458	Phenobarbital	III	PHADIA DIAGNOSTICOS LTDA	26/06/2023	Until 26/06/2033
CEDIA Theophylline II Assay 80254180409	Theophylline	III	PHADIA DIAGNOSTICOS LTDA	18/04/2022	Until 18/04/2032
Família QMS Amikacin Immunoassay 80254180402	Amikacin	II	PHADIA DIAGNOSTICOS LTDA	10/01/2022	Valid
QMS Gentamicin Immunoassay 80254180391	Gentamicin	II	PHADIA DIAGNOSTICOS LTDA	16/08/2021	Valid
CEDIA Carbamazepine II Assay 80254180388	Carbamazepine	III	PHADIA DIAGNOSTICOS LTDA	31/05/2021	Until 31/05/2031
QMS Vancomycin Immunoassay 80254180384	Vancomycin	III	PHADIA DIAGNOSTICOS LTDA	15/03/2021	Until 15/03/2031
CEDIA® Core TDM Multi-Calibrators 80254180381	Combined parameters in one product - class III	III	PHADIA DIAGNOSTICOS LTDA	30/12/2020	Until 30/12/2030
Alinity c Methadone Reagent Kit 80146502322	Methadone	II	ABBOTT LABORATORIOS DO BRASIL LTDA	17/12/2020	Valid
Alinity c Propoxyphene Reagent Kit 80146502323	Propoxyphene	II	ABBOTT LABORATORIOS DO BRASIL LTDA	17/12/2020	Valid
Alinity c Tricyclic Antidepressants Reagent Kit 80146502318	Tricyclic antidepressants	II	ABBOTT LABORATORIOS DO BRASIL LTDA	10/12/2020	Valid
Alinity c Phencyclidine Reagent Kit 80146502312	Phencyclidine (PCP)	II	ABBOTT LABORATORIOS DO BRASIL LTDA	26/11/2020	Valid
Família Alinity c Benzodiazepines 80146502314	Benzodiazepines	II	ABBOTT LABORATORIOS DO BRASIL LTDA	26/11/2020	Valid
Alinity c Amphetamine/Methamphetamine Reagent Kit 80146502302	Amphetamine	II	ABBOTT LABORATORIOS DO BRASIL LTDA	01/10/2020	Valid
Alinity c DOA MC I Controls 80146502301	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	24/09/2020	Valid
Família Alinity c Tox Calibrator and Control 80146502293	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	21/09/2020	Valid
Família Alinity c DOA MC Calibrator Kit 80146502294	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	21/09/2020	Valid
Alinity c DOA MC Qual Low Calibrator 1 Kit 80146502295	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	21/09/2020	Valid
Alinity c DOA MC II Controls 80146502296	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	21/09/2020	Valid
Alinity c DOA MC III Controls 80146502297	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	21/09/2020	Valid
Alinity c DOA MC Negative Calibrator Kit 80146502298	Combined parameters in one product - class II	II	ABBOTT LABORATORIOS DO BRASIL LTDA	21/09/2020	Valid
Alinity c Barbiturates Reagent Kit 80146502287	Barbiturates	II	ABBOTT LABORATORIOS DO BRASIL LTDA	14/09/2020	Valid
Família Alinity c Opiates 80146502288	Opiates	II	ABBOTT LABORATORIOS DO BRASIL LTDA	14/09/2020	Valid
Família Alinity c Ecstasy 80146502289	Methamphetamine	II	ABBOTT LABORATORIOS DO BRASIL LTDA	14/09/2020	Valid
Alinity c Serum Benzodiazepines Reagent Kit 80146502285	Benzodiazepines	II	ABBOTT LABORATORIOS DO BRASIL LTDA	08/09/2020	Valid
Alinity c Carbamazepine Reagent Kit 80146502286	Carbamazepine	III	ABBOTT LABORATORIOS DO BRASIL LTDA	08/09/2020	Until 26/05/2035
Alinity c Cocaine Reagent Kit 80146502279	Cocaine	II	ABBOTT LABORATORIOS DO BRASIL LTDA	31/08/2020	Valid
Família Alinity c Cannabinoids 80146502280	Cannabinoids	II	ABBOTT LABORATORIOS DO BRASIL LTDA	31/08/2020	Valid
Alinity c Amikacin Reagent Kit 80146502274	Amikacin	II	ABBOTT LABORATORIOS DO BRASIL LTDA	24/08/2020	Valid
Família MAS UrichemTRAK 80254180364	Combined parameters in one product - class II	II	PHADIA DIAGNOSTICOS LTDA	03/08/2020	Valid
Família MAS Liquimmune 80254180362	Combined parameters in one product - class III	III	PHADIA DIAGNOSTICOS LTDA	27/07/2020	Until 27/07/2030
Família MAS DOA TOTAL 80254180351	Combined parameters in one product - class II	II	PHADIA DIAGNOSTICOS LTDA	16/03/2020	Valid
Família MAS chemTRAK-H 80254180352	Combined parameters in one product - class III	III	PHADIA DIAGNOSTICOS LTDA	16/03/2020	Until 16/03/2030
MAS UA DipTube 80254180353	Combined parameters in one product - class II	II	PHADIA DIAGNOSTICOS LTDA	16/03/2020	Valid
Família MAS PAR TDM 80254180350	Combined parameters in one product - class III	III	PHADIA DIAGNOSTICOS LTDA	09/03/2020	Until 09/03/2030
Família MAS Urinalysis 80254180348	Combined parameters in one product - class II	II	PHADIA DIAGNOSTICOS LTDA	02/03/2020	Valid
Família MAS UA 80254180349	Combined parameters in one product - class II	II	PHADIA DIAGNOSTICOS LTDA	02/03/2020	Valid
MAS Alcohol/Ammonia 80254180339	Combined parameters in one product - class II	II	PHADIA DIAGNOSTICOS LTDA	27/01/2020	Valid
Família MAS Bilirubin 80254180340	Bilirubin	II	PHADIA DIAGNOSTICOS LTDA	27/01/2020	Valid
Família MAS Immunology 80254180341	Combined parameters in one product - class II	II	PHADIA DIAGNOSTICOS LTDA	27/01/2020	Valid
MAS Diabetes 80254180342	Glycated hemoglobin (HbA1c)	II	PHADIA DIAGNOSTICOS LTDA	27/01/2020	Valid
MAS CSF 80254180343	Combined parameters in one product - class II	II	PHADIA DIAGNOSTICOS LTDA	27/01/2020	Valid
Família MAS T-Marker 80254180336	Combined parameters in one product - class III	III	PHADIA DIAGNOSTICOS LTDA	23/12/2019	Until 23/12/2029
Família MAS Omni Immune PRO 80254180337	Combined parameters in one product - class III	III	PHADIA DIAGNOSTICOS LTDA	23/12/2019	Until 23/12/2029
Família MAS Omni Immune 80254180333	Combined parameters in one product - class III	III	PHADIA DIAGNOSTICOS LTDA	02/12/2019	Until 02/12/2029

MICROGENICS CORPORATION

Brazilian registration holders

Device types

Registrations (page 1 of 2, newest first)