LABTEST DIAGNOSTICA S/A

Brazilian registration holder · CNPJ 16.516.296/0001-38

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511registrations

281currently valid

20manufacturers

136device types

1994first registration

77class I

284class II

66class III

35class IV

49old classification

Registrations (page 3 of 11, highest registration number first)

Product	Device type	Class	Manufacturer	Published	Status
SHBG Reagent Kit 10009010412	Sex hormone-binding globulin (SHBG)	II	LABTEST DIAGNOSTICA S/A	27/11/2023	Valid
Progesterone Reagent Kit 10009010411	Progesterone	II	LABTEST DIAGNOSTICA S/A	20/11/2023	Valid
Concentrated Wash Buffer 10009010410	Buffers, diluents and other solutions for laboratory analysis	I	LABTEST DIAGNOSTICA S/A	13/11/2023	Valid
Família Audmax 400 10009010409	Analyzer for general chemistry, hormones, drugs or proteins	II	DIRUI INDUSTRIAL CO. LTD	30/10/2023	Valid
Lab Rapid Dengue NS1 10009010408	Dengue	III	LABTEST DIAGNOSTICA S/A	09/10/2023	Until 09/10/2033
Família CS-1500 10009010407	Immunoassay instrument	II	VIRTUE DIAGNOSTICS SUZHOU CO. LTD.	18/09/2023	Valid
Família CS-3000 10009010406	Immunoassay instrument	II	VIRTUE DIAGNOSTICS SUZHOU CO. LTD.	11/09/2023	Valid
LH Reagent Kit 10009010405	Luteinizing hormone (LH)	II	LABTEST DIAGNOSTICA S/A	14/08/2023	Valid
System Maintenance Fluid 10009010404	Not yet published	I	Not yet published	14/08/2023	Cancelled 31/03/2025
Pre-Trigger Solution 10009010403	Buffers, diluents and other solutions for laboratory analysis	I	LABTEST DIAGNOSTICA S/A	14/08/2023	Valid
Trigger Solution 10009010402	Buffers, diluents and other solutions for laboratory analysis	I	LABTEST DIAGNOSTICA S/A	14/08/2023	Valid
AMH Reagent Kit 10009010401	Anti-Müllerian hormone (AMH)	II	LABTEST DIAGNOSTICA S/A	24/07/2023	Valid
Estradiol Reagent Kit 10009010400	Estradiol	II	LABTEST DIAGNOSTICA S/A	03/07/2023	Valid
Testosterone Reagent Kit 10009010399	Testosterone	II	LABTEST DIAGNOSTICA S/A	03/07/2023	Valid
ß-HCG Reagent Kit 10009010398	Beta human chorionic gonadotropin (beta-hCG) - tumor marker / congenital disorders	III	LABTEST DIAGNOSTICA S/A	03/07/2023	Until 10/03/2035
FSH Reagent Kit 10009010397	Follicle-stimulating hormone (FSH)	II	LABTEST DIAGNOSTICA S/A	03/07/2023	Valid
PRL Reagent Kit 10009010396	Prolactin	II	LABTEST DIAGNOSTICA S/A	29/05/2023	Valid
PGI Reagent Kit 10009010395	Pepsinogen I	II	LABTEST DIAGNOSTICA S/A	29/05/2023	Valid
PGII Reagent Kit 10009010394	Pepsinogen II	II	LABTEST DIAGNOSTICA S/A	29/05/2023	Valid
ProGRP Reagent Kit 10009010393	Gastrin-releasing peptide (ProGRP)	III	LABTEST DIAGNOSTICA S/A	29/05/2023	Until 10/02/2035
TG Reagent Kit 10009010392	Thyroglobulin (Tg) - tumor marker	III	LABTEST DIAGNOSTICA S/A	29/05/2023	Until 24/03/2035
Audmax 600 10009010391	Analyzer for general chemistry, hormones, drugs or proteins	II	DIRUI INDUSTRIAL CO. LTD	29/05/2023	Valid
Audmax 240 10009010390	Analyzer for general chemistry, hormones, drugs or proteins	II	DIRUI INDUSTRIAL CO. LTD	22/05/2023	Valid
Família Aud-H5 10009010389	Cell and platelet analyzer or counter	II	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD	02/05/2023	Valid
Família Aud-H 5AL 10009010388	Cell and platelet analyzer or counter	II	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD	17/04/2023	Valid
Família Aud-H3 10009010387	Cell and platelet analyzer or counter	II	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD	17/04/2023	Valid
Família Audmax 360 10009010386	Analyzer for general chemistry, hormones, drugs or proteins	II	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD	17/04/2023	Valid
Família HbA1c WH Turbiquest 10009010385	Glycated hemoglobin (HbA1c)	II	LABTEST DIAGNOSTICA S/A	21/11/2022	Valid
Família HDL LE 10009010384	High-density lipoprotein (HDL)	II	LABTEST DIAGNOSTICA S/A	20/10/2022	Valid
Família HDL 10009010383	High-density lipoprotein (HDL)	II	LABTEST DIAGNOSTICA S/A	20/10/2022	Valid
Família Qualitrol Proteínas U/LCR 10009010382	Total protein	II	LABTEST DIAGNOSTICA S/A	18/08/2022	Valid
MyTest COVID-19 Ag Nasal 10009010381	Self-test for SARS-CoV-2 (coronavirus) antigen	III	LABTEST DIAGNOSTICA S/A	25/04/2022	Until 25/04/2032
Família Sódio 10009010380	Sodium	II	LABTEST DIAGNOSTICA S/A	24/02/2022	Valid
COVID-19 anti-RBD Total Rapid Test 10009010379	Not yet published	III	Not yet published	04/10/2021	Cancelled 15/07/2024
Influenza A/B/H1N1 Ag Rapid Test Combo 10009010378	Influenza A and B viruses	III	LABTEST DIAGNOSTICA S/A	04/10/2021	Until 04/10/2031
Detect SARS-CoV-2 (RT-PCR) Fast 10009010377	Coronavirus	III	LABTEST DIAGNOSTICA S/A	16/08/2021	Until 16/08/2031
Virolens Sampling Kit 10009010376	Container or material for collection, storage or transport of biological samples	I	LABTEST DIAGNOSTICA S/A	22/07/2021	Valid
Nucleic Acid Extraction Kit (Magnetic Bead Method) 10009010375	Buffers, diluents and other solutions for laboratory analysis	I	ZYBIO INC.	01/07/2021	Valid
COVID-19 Ag Rapid Test (Swab Naso/Oro) 10009010374	Coronavirus	III	LABTEST DIAGNOSTICA S/A	21/06/2021	Until 21/06/2031
Anti SARS-CoV-2 & M. pneumoniae IgG/IgM Rapid Test Combo 10009010373	Combined parameters - respiratory panel	III	LABTEST DIAGNOSTICA S/A	14/06/2021	Until 14/06/2031
COVID-19 & FLU A/B Ag Rapid Test Combo 10009010372	Combined parameters - respiratory panel	III	LABTEST DIAGNOSTICA S/A	14/06/2021	Until 14/06/2031
Covid-19 Ag Rapid Test (Oral Fluid) 10009010371	Coronavirus	III	LABTEST DIAGNOSTICA S/A	31/05/2021	Until 31/05/2031
HIV Triline 1/2 Rapid Test 10009010370	Not yet published	IV	Not yet published	17/05/2021	Cancelled 31/03/2025
MyTest - Kit para autocoleta de saliva 10009010369	Not yet published	I	Not yet published	15/04/2021	Cancelled 24/02/2025
OmniLAMP SARS-CoV-2 (PCR-LAMP) 10009010368	Not yet published	III	Not yet published	01/03/2021	Cancelled 26/12/2022
Anti SARS-CoV-2 IgG 10009010367	Not yet published	III	Not yet published	17/02/2021	Cancelled 15/07/2024
Lab Rapid Dengue IgG/IgM 10009010366	Dengue	III	LABTEST DIAGNOSTICA S/A	04/01/2021	Until 04/01/2031
Lab Rapid HIV Tri Line 1/2 10009010365	HIV-1/HIV-2 antibody	IV	LABTEST DIAGNOSTICA S/A	21/12/2020	Until 21/12/2030
Anti SARS-CoV-2 IgM/IgG Rapid Test SD 10009010364	Coronavirus	III	LABTEST DIAGNOSTICA S/A	12/11/2020	Until 12/11/2030
Lab Rapid HBsAg 10009010363	Hepatitis B surface antigen (HBsAg)	IV	LABTEST DIAGNOSTICA S/A	16/11/2020	Until 16/11/2030