| DT 100
80615959001 |
Not yet published |
II |
Not yet published |
30/11/2015 |
Cancelled 13/05/2024 |
| AutoMic-i600
80615950276 |
Microorganism identification or susceptibility testing instrument |
II |
AUTOBIO LABTEC INSTRUMENTS CO., LTD |
17/04/2023 |
Valid |
| SISTEMA DE DETECÇÃO MICROBIANA
80615950275 |
Blood culture system (microorganism growth detection) |
II |
AUTOBIO LABTEC INSTRUMENTS CO., LTD |
08/09/2022 |
Valid |
| FAMÍLIA AUTOF MS
80615950274 |
Microorganism identification or susceptibility testing instrument |
II |
AUTOBIO DIAGNOSTICS CO., LTD |
15/06/2022 |
Valid |
| FRASCOS DE CULTURA MICOBACTERIANA
80615950273 |
Differential culture media and devices for biochemical identification of microorganisms |
I |
AUTOBIO DIAGNOSTICS CO., LTD. |
28/04/2022 |
Valid |
| REAGENTE DE PRÉ TRATAMENTO DE HEMOCULTURAS POSITIVAS
80615950272 |
Buffers, diluents and other solutions for laboratory analysis |
I |
AUTOBIO DIAGNOSTICS CO., LTD |
28/04/2022 |
Valid |
| MATRIZ CHCA PARA USO COM AUTOF MS
80615950271 |
Buffers, diluents and other solutions for laboratory analysis |
I |
AUTOBIO DIAGNOSTICS CO., LTD |
28/04/2022 |
Valid |
| CALIBRADOR PARA USO COM AUTOF MS
80615950270 |
Solution for performance testing of equipment components |
I |
AUTOBIO DIAGNOSTICS CO., LTD |
28/04/2022 |
Valid |
| REAGENTE PRÉ TRATAMENTO PARA FUNGOS FILAMENTOSOS
80615950269 |
Buffers, diluents and other solutions for laboratory analysis |
I |
AUTOBIO DIAGNOSTICS CO., LTD |
28/04/2022 |
Valid |
| Teste Rápido Domiciliar AUTOBIO SARS-CoV-2 Ag
80615950268 |
Self-test for SARS-CoV-2 (coronavirus) antigen |
III |
AUTOBIO DIAGNOSTICS CO., LTD. |
04/04/2022 |
Until 04/04/2032 |
| Teste Humasis COVID-19 / Flu Ag Combo
80615950267 |
Combined parameters - respiratory panel |
III |
HUMASIS CO., LTD |
04/04/2022 |
Until 04/04/2032 |
| FAMÍLIA SARS-CoV-2 ELITe MGB® Kit
80615950266 |
Not yet published |
III |
Not yet published |
19/10/2020 |
Cancelled 05/12/2021 |
| Humasis COVID-19 Ag
80615950265 |
Coronavirus |
III |
HUMASIS CO., LTD |
01/10/2020 |
Until 01/10/2030 |
| ICRP - TURBI
80615950264 |
C-reactive protein (CRP) |
II |
ELITECH CLINICAL SYSTEMS SAS |
21/09/2020 |
Valid |
| FAMÍLIA DE CONTROLES SPINTROL H NORMAL e SPINTROL H PATOLÓGICO
80615950263 |
Combined parameters in one product - class II |
II |
SPINREACT S.A.U. |
08/09/2020 |
Valid |
| ANTI-ESTREPTOLISINA O
80615950262 |
Antistreptolysin |
II |
ELITECH CLINICAL SYSTEMS SAS |
24/08/2020 |
Valid |
| KIT MERIL BILIRRUBINA TOTAL
80615950261 |
Bilirubin |
II |
MERIL DIAGNOSTICS PVT.LTD. |
10/08/2020 |
Valid |
| MERIL KIT BILIRRUBINA DIRETA
80615950260 |
Bilirubin |
II |
MERIL DIAGNOSTICS PVT. LTD |
10/08/2020 |
Valid |
| FAMÍLIA VITAMINA D
80615950259 |
Not yet published |
II |
Not yet published |
03/08/2020 |
Cancelled 05/04/2021 |
| Merylizer AutoQuant 100i
80615950258 |
Analyzer for general chemistry, hormones, drugs or proteins |
II |
MERIL DIAGNOSTICS PVT.LTD. |
20/07/2020 |
Valid |
| Teste rápido Anti-SARS-CoV-2
80615950257 |
Coronavirus |
III |
AUTOBIO DIAGNOSTICS CO., LTD. |
18/06/2020 |
Until 18/06/2030 |
| MERIL KIT CREATINA QUINASE
80615950256 |
Creatine kinase (CK) |
II |
MERIL DIAGNOSTICS PVT.LTD. |
10/02/2020 |
Valid |
| HUBI TSH
80615950255 |
Thyroid-stimulating hormone (TSH) |
II |
HUMASIS CO., LTDA |
27/01/2020 |
Valid |
| FAMÍLA MAGNÉSIO XYLIDIL
80615950254 |
Magnesium |
II |
DAILYTECH LATINO AMERICA LTDA
ELITECH CLINICAL SYSTEMS SAS |
16/12/2019 |
Valid |
| AUTOF MS 1000
80615950253 |
Microorganism identification or susceptibility testing instrument |
II |
AUTOBIO DIAGNOSTICS CO., LTD |
16/12/2019 |
Valid |
| Família Microproteína Plus
80615950252 |
Microprotein (urine microalbumin/protein) |
II |
ELITECH CLINICAL SYSTEMS SAS |
02/12/2019 |
Valid |
| HUBI PSA
80615950251 |
Prostate-specific antigen (PSA) |
III |
HUMASIS CO., LTDA |
25/11/2019 |
Until 25/11/2029 |
| GLICOSE PAP SL
80615950250 |
Glucose |
II |
VITAL SCIENTIFIC B.V. |
25/11/2019 |
Valid |
| LIPASE SL
80615950249 |
Lipase |
II |
ELITECH CLINICAL SYSTEMS SAS |
25/11/2019 |
Valid |
| HUMASIS FOB
80615950248 |
Fecal occult blood |
III |
HUMASIS CO., LTDA |
25/11/2019 |
Until 25/11/2029 |
| Macroduct Advanced
80615950247 |
Not yet published |
I |
Not yet published |
13/11/2019 |
Cancelled 02/12/2019 |
| Selectra Pro M
80615950246 |
Analyzer for general chemistry, hormones, drugs or proteins |
II |
ELITECH GROUP BV |
11/11/2019 |
Valid |
| POTÁSSIO
80615950245 |
Potassium |
II |
SPINREACT,S.A./S.A.U. |
04/11/2019 |
Valid |
| SÓDIO
80615950244 |
Sodium |
II |
SPINREACT,S.A./S.A.U. |
04/11/2019 |
Valid |
| DIESTRO TRILEVEL REF.: IN 0750
80615950243 |
Electrolytes |
II |
JS MEDICINA ELECTRONICA S.R.L |
04/11/2019 |
Valid |
| REAGENTE DE PRE TRATAMENTO DE AMOSTRAS
80615950242 |
Buffers, diluents and other solutions for laboratory analysis |
I |
AUTOBIO DIAGNOSTICS CO., LTD |
24/10/2019 |
Valid |
| HUMASIS INFLUENZA A/B CARD PLUS
80615950241 |
Influenza A and B viruses |
III |
HUMASIS CO., LTD |
29/10/2019 |
Until 29/10/2029 |
| Família Ferro Ferene
80615950240 |
Iron |
II |
VITALSCIENTIFIC |
21/10/2019 |
Valid |
| FAMILIA DE CONTROLES E CALIBRADORES MERIL
80615950239 |
Combined parameters in one product - class II |
II |
MERIL DIAGNOSTICS PVT. LTD. |
14/10/2019 |
Valid |
| FAMÍLIA MRSA/SA ELITe MGB®
80615950238 |
Not yet published |
III |
Not yet published |
07/10/2019 |
Cancelled 05/12/2021 |
| Família Painel Respiratório Viral ELITe MGB®
80615950237 |
Not yet published |
III |
Not yet published |
30/09/2019 |
Cancelled 05/12/2021 |
| FAMÍLIA CHLAMYDIA TR. ELITe MGB® KIT
80615950236 |
Not yet published |
III |
Not yet published |
23/09/2019 |
Cancelled 05/12/2021 |
| MERIL CELQUANT 360 RINSE
80615950235 |
Buffers, diluents and other solutions for laboratory analysis |
I |
MERIL DIAGNOSTIC PVT LTD. |
19/09/2019 |
Valid |
| MERIL CELQUANT 360 DIELUENTE
80615950234 |
Buffers, diluents and other solutions for laboratory analysis |
I |
MERIL DIAGNOSTICS PVT.LTD. |
19/09/2019 |
Valid |
| MERIL CELQUANT 360 LYSE
80615950233 |
Lysis solution |
I |
Not yet published |
19/09/2019 |
Valid |
| HUBI DUO
80615950232 |
Combined parameters in one product - class III |
III |
HUMASIS CO., LTDA |
19/08/2019 |
Until 19/08/2029 |
| HUBI CK-MB
80615950231 |
Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM) |
III |
HUMASIS CO., LTDA |
19/08/2019 |
Until 19/08/2029 |
| HUMASIS INFLUENZA A/B ANTIGEN TEST STRIP
80615950230 |
Influenza A and B viruses |
III |
HUMASIS CO., LTDA |
12/08/2019 |
Until 12/08/2029 |
| ESTERILIZADOR HORIZONTAL PROHS
80615950229 |
Autoclave |
II |
PROHS EQUIPAMENTO HOSPITALAR E SERVIÇOS ASSOCIADOS, S.A. |
12/08/2019 |
Valid |
| HUMASIS PSA CARD
80615950228 |
Prostate-specific antigen (PSA) |
III |
HUMASIS CO., LTDA |
15/07/2019 |
Until 15/07/2029 |