| ANALISADOR DE URINA LUMIRATEK
81327670100 |
Urine analyzer |
II |
ACON LABORATORIES, INC |
26/11/2018 |
Valid |
| Controle Líquido de Urina Lumiratek
81327670099 |
Combined parameters in one product - class II |
II |
ACON LABORATORIES, INC. |
26/11/2018 |
Valid |
| Família Controle mLabs Painel Cardíaco 3
81327670098 |
Combined parameters in one product - class III |
III |
MICROPOINT BIOSCIENCE INC. |
29/10/2018 |
Until 29/10/2028 |
| CARTUCHO DE LUMIRATEK i15 – MODELO BG8
81327670097 |
Combined parameters in one product - class II |
II |
EDAN INSTRUMENTS, INC. |
23/07/2018 |
Valid |
| CARTUCHO PARA LUMIRATEK i15 - MODELO BG3
81327670096 |
Buffers, diluents and other solutions for laboratory analysis |
I |
EDAN INSTRUMENTS, INC. |
23/07/2018 |
Valid |
| CONTROLE LUMIRATEK i15
81327670095 |
Electrolytes |
II |
EDAN INSTRUMENTS, INC. |
23/07/2018 |
Valid |
| ANALISADOR LUMIRATEK i15
81327670094 |
Analyzer for blood gases, ions or pH |
II |
EDAN INSTRUMENTS, INC. |
23/07/2018 |
Valid |
| CALIBRADOR PARA LUMIRATEK i15
81327670093 |
Combined parameters in one product - class II |
II |
EDAN INSTRUMENTS, INC. |
23/07/2018 |
Valid |
| CARTUCHO PARA LUMIRATEK i15 - MODELO BG10
81327670092 |
Combined parameters in one product - class II |
II |
EDAN INSTRUMENTS, INC. |
23/07/2018 |
Valid |
| ANALISADOR AUTOMÁTICO DE HEMATOLOGIA - ICON 5
81327670091 |
Not yet published |
II |
Not yet published |
12/03/2018 |
Cancelled 02/12/2018 |
| FAMÍLIA DE CONTROLES PARA HEMATOLOGIA Cont5+
81327670090 |
Not yet published |
II |
Not yet published |
06/11/2017 |
Cancelled 02/12/2018 |
| LUMIRATEK DENGUE IgG / IgM - CASSETE
81327670089 |
Dengue |
III |
HANGZHOU BIOTEST BIOTECH CO., LTD |
16/10/2017 |
Until 16/10/2027 |
| FAMÍLIA DE REAGENTES PARA HEMATOLOGIA - iCON 5
81327670088 |
Not yet published |
I |
Not yet published |
09/10/2017 |
Cancelled 02/12/2018 |
| SPOTCHEM TIRA REATIVA QUIMICA SECA – CÁLCIO
81327670087 |
Calcium |
II |
ARKRAY FACTORY, INC. |
28/08/2017 |
Valid |
| SPOTCHEM TIRA REATIVA QUIMICA SECA – MAGNÉSIO
81327670086 |
Magnesium |
II |
ARKRAY FACTORY, INC. |
28/08/2017 |
Valid |
| PAINEL PERFIL HEPÁTICO E LIPÍDICO (TGP, TGO, GGT, TG, T-Cho, HDL-c)
81327670085 |
Combined parameters in one product - class II |
II |
ARKRAY FACTORY, INC. |
31/07/2017 |
Valid |
| LUMIRATEK HBsAG - CASSETE
81327670084 |
Hepatitis B surface antigen (HBsAg) |
IV |
HANGZHOU BIOTEST BIOTECH CO., LTD |
31/07/2017 |
Until 31/07/2027 |
| LUMIRATEK HCV - CASSETE
81327670083 |
Total antibody to hepatitis C virus (anti-HCV) |
IV |
HANGZHOU BIOTEST BIOTECH CO., LTD |
31/07/2017 |
Until 31/07/2027 |
| LUMIRATEK DENGUE Ab e Ag - DUO
81327670082 |
Dengue |
III |
HANGZHOU BIOTEST BIOTECH CO. LTD. |
31/07/2017 |
Until 31/07/2027 |
| LUMIRATEK HCV + HIV + SÍFILIS - CASSETE
81327670081 |
HIV, HCV and syphilis antibodies |
IV |
HANGZHOU BIOTEST BIOTECH CO. LTD. |
24/07/2017 |
Until 24/07/2027 |
| LUMIRATEK SÍFILIS + HIV - CASSETE
81327670080 |
HIV-1/HIV-2 and Treponema pallidum antibodies |
IV |
HANGZHOU BIOTEST BIOTECH CO. LTD. |
24/07/2017 |
Until 24/07/2027 |
| LUMIRATEK HIV 1.2 O Tri-Line – CASSETE
81327670079 |
Antibody to human immunodeficiency virus type 1, type 2 and type 1 group O (HIV) |
IV |
HANGZHOU BIOTEST BIOTECH CO., LTD |
27/03/2017 |
Until 27/03/2027 |
| TIRA REATIVA LUMIRATEK PERFIL LIPÍDICO
81327670078 |
Not yet published |
II |
Not yet published |
27/03/2017 |
Cancelled 15/07/2024 |
| SOLUÇÃO CONTROLE LUMIRATEK PERFIL LIPÍDICO
81327670077 |
Not yet published |
II |
Not yet published |
13/03/2017 |
Cancelled 15/07/2024 |
| SOLUÇÃO CONTROLE LUMIRATEK GLICOSE
81327670076 |
Not yet published |
II |
Not yet published |
13/03/2017 |
Cancelled 15/07/2024 |
| FAMILIA LUMIRATEK TUBERCULOSE
81327670075 |
Not yet published |
III |
Not yet published |
13/03/2017 |
Cancelled 15/07/2024 |
| LUMIRATEK MIOGLOBINA/CKMB/TROPONINA I COMBO – CASSETE
81327670074 |
Combined parameters in one product - class III |
III |
HANGZHOU BIOTEST BIOTECH CO., LTD |
13/03/2017 |
Until 13/03/2027 |
| TIRA REATIVA LUMIRATEK GLICOSE
81327670073 |
Not yet published |
II |
Not yet published |
01/03/2017 |
Cancelled 15/07/2024 |
| CONTROLE HbA1c LUMIRATEK C
81327670072 |
Not yet published |
II |
Not yet published |
01/03/2017 |
Cancelled 15/07/2024 |
| ANALISADOR LUMIRATEK C
81327670071 |
Not yet published |
II |
Not yet published |
20/02/2017 |
Cancelled 15/07/2024 |
| KIT DE TESTE DE PCR LUMIRATEK C
81327670070 |
Not yet published |
II |
Not yet published |
20/02/2017 |
Cancelled 15/07/2024 |
| KIT DE TESTE DE MICRO- ALBUMINA LUMIRATEK C
81327670069 |
Not yet published |
II |
Not yet published |
20/02/2017 |
Cancelled 15/07/2024 |
| FAMILIA LUMIRATEK SIFILIS
81327670068 |
Treponema pallidum |
IV |
HANGZHOU BIOTEST BIOTECH CO., LTD |
06/02/2017 |
Until 06/02/2027 |
| LUMIRATEK DENGUE NS1 - CASSETE
81327670067 |
Dengue |
III |
HANGZHOU BIOTEST BIOTECH CO., LTD |
06/02/2017 |
Until 06/02/2027 |
| CONTROLE MICRO-ALBUMINA LUMIRATEK C
81327670066 |
Not yet published |
II |
Not yet published |
30/01/2017 |
Cancelled 15/07/2024 |
| CONTROLE PCR LUMIRATEK C
81327670065 |
Not yet published |
II |
Not yet published |
30/01/2017 |
Cancelled 15/07/2024 |
| LUMIRATEK H. PYLORY - CASSETE
81327670064 |
Helicobacter pylori |
II |
HANGZHOU BIOTEST BIOTECH CO., LTD |
23/01/2017 |
Valid |
| Cartucho de teste mLabs D-Dimero
81327670063 |
D-dimer |
III |
MICROPOINT BIOSCIENCE INC. |
23/01/2017 |
Until 23/01/2027 |
| Cartucho de Teste mLabs Troponina
81327670062 |
Troponin |
III |
MICROPOINT BIOSCIENCE INC. |
23/01/2017 |
Until 23/01/2027 |
| KIT DE TESTE DE HbA1c LUMIRATEK C
81327670061 |
Not yet published |
II |
Not yet published |
23/01/2017 |
Cancelled 15/07/2024 |
| Cartucho de teste mLabs PAINEL CARDÍACO 3
81327670060 |
Multi-analyte calibrators and standards, one or more concentrations - class III |
III |
MICROPOINT BIOSCIENCE INC. |
23/01/2017 |
Until 23/01/2027 |
| CONTROLE HEMATOLÓGICO LUMIRATEK H3
81327670059 |
Not yet published |
II |
Not yet published |
12/12/2016 |
Cancelled 15/07/2024 |
| CALIBRADOR HEMATOLÓGICO LUMIRATEK
81327670058 |
Not yet published |
II |
Not yet published |
07/11/2016 |
Cancelled 15/07/2024 |
| CONTROLE HEMATOLÓGICO LUMIRATEK H5
81327670057 |
Not yet published |
II |
Not yet published |
07/11/2016 |
Cancelled 15/07/2024 |
| LUMIRATEK STREP A – CASSETE
81327670056 |
Streptococcus |
III |
HANGZHOU BIOTEST BIOTECH CO., LTD |
31/10/2016 |
Until 31/10/2026 |
| LUMIRATEK ROTAVÍRUS/ADENOVÍRUS - CASSETE
81327670055 |
Combined parameters in one product - class II |
II |
HANGZHOU BIOTEST BIOTECH CO., LTD |
31/10/2016 |
Valid |
| LUMIRATEK TOXO IgG/IgM - CASSETE
81327670054 |
Toxoplasma gondii IgG/IgM |
IV |
HANGZHOU BIOTEST BIOTECH CO., LTD |
24/10/2016 |
Until 24/10/2026 |
| FAMILIA LUMIRATEK LH
81327670053 |
Not yet published |
II |
Not yet published |
24/10/2016 |
Cancelled 27/05/2019 |
| LUMIRATEK HAV IgM - CASSETE
81327670052 |
Hepatitis A virus (HAV) |
III |
HANGZHOU BIOTEST BIOTECH CO., LTD |
24/10/2016 |
Until 24/10/2026 |
| LUMIRATEK TROPONINA I - CASSETE
81327670051 |
Troponin |
III |
HANGZHOU BIOTEST BIOTECH CO., LTD |
24/10/2016 |
Until 24/10/2026 |