| Família Cassete de Teste Rápido de PCT (Sangue Total/Soro/Plasma)
81325990418 |
Procalcitonin (PCT) |
III |
HANGZHOU ALLTEST BIOTECH CO. LTD |
15/12/2025 |
Until 15/12/2035 |
| Família Cassete de Teste de Troponina Cardíaca de Alta Sensibilidade (Sangue total/Soro/Plasma)
81325990417 |
Troponin |
III |
ACRO BIOTECH, INC. (MONTCLAIR) |
15/12/2025 |
Until 15/12/2035 |
| Família Cassete de teste para NT-proBNP (Sangue Total/Plasma)
81325990416 |
Human brain natriuretic peptide (BNP) |
III |
ACRO BIOTECH, INC. (MONTCLAIR) |
10/11/2025 |
Until 10/11/2035 |
| Projetor de gráficos
81325990415 |
Ophthalmic chart projector |
I |
HUVITZ CO LTD |
03/11/2025 |
Valid |
| Urinalysis Turbidity Calibrator
81325990414 |
Solution for performance testing of equipment components |
I |
MACCURA BIOTECHNOLOGY CO LTD |
03/11/2025 |
Valid |
| Instest Plus Analisador de Urina
81325990413 |
Urine analyzer |
II |
ACRO BIOTECH, INC. (MONTCLAIR) |
03/11/2025 |
Valid |
| Urinalysis Sediment Calibrator
81325990412 |
Solution for performance testing of equipment components |
I |
MACCURA BIOTECHNOLOGY CO LTD |
03/11/2025 |
Valid |
| Urinalysis Sediment Focus Fluid
81325990411 |
Solution for performance testing of equipment components |
I |
MACCURA BIOTECHNOLOGY CO LTD |
24/10/2025 |
Valid |
| Urinalysis Specific Gravity control
81325990410 |
Solution for performance testing of equipment components |
I |
MACCURA BIOTECHNOLOGY CO LTD |
24/10/2025 |
Valid |
| Urinalysis Specific Gravity Calibrator
81325990409 |
Solution for performance testing of equipment components |
I |
MACCURA BIOTECHNOLOGY CO LTD |
24/10/2025 |
Valid |
| Urine Analysis Color Control
81325990408 |
Solution for performance testing of equipment components |
I |
MACCURA BIOTECHNOLOGY CO LTD |
24/10/2025 |
Valid |
| Urinalysis Sediment Control
81325990407 |
Solution for performance testing of equipment components |
I |
MACCURA BIOTECHNOLOGY CO LTD |
24/10/2025 |
Valid |
| Urinalysis Turbidity Control
81325990406 |
Solution for performance testing of equipment components |
I |
MACCURA BIOTECHNOLOGY CO LTD |
24/10/2025 |
Valid |
| Urinalysis Sediment Sheath Fluid
81325990405 |
Buffers, diluents and other solutions for laboratory analysis |
I |
MACCURA BIOTECHNOLOGY CO LTD |
24/10/2025 |
Valid |
| Urinalysis Control
81325990404 |
Combined parameters in one product - class II |
II |
MACCURA BIOTECHNOLOGY CO LTD |
24/10/2025 |
Valid |
| Família Sistema de Urinálise Automático
81325990403 |
Urine analyzer |
II |
MACCURA MEDICAL INSTRUMENT CO., LTD. |
13/10/2025 |
Valid |
| Família de Teste rápido combinado em cassete para GDH + Toxina A + Toxina B da Clostridium difficile (Fezes)
81325990402 |
Combined parameters in one product - class III |
III |
ACRO BIOTECH, INC. (MONTCLAIR) |
13/10/2025 |
Until 13/10/2035 |
| Família Cassete de Teste para PCT (Sangue Total, Soro, Plasma)
81325990401 |
Procalcitonin (PCT) |
III |
ACRO BIOTECH, INC. (MONTCLAIR) |
06/10/2025 |
Until 06/10/2035 |
| Teste Rápido Combinado em Cassete para HIV 1.2 e P24 (Sangue Total/Soro/Plasma)
81325990400 |
Combined parameters in one product - class IV |
IV |
HANGZHOU ALLTEST BIOTECH CO. LTD |
22/09/2025 |
Until 22/09/2035 |
| FluroLit Analisador de Imunoensaio de Fluorescência
81325990399 |
Immunoassay instrument |
II |
ACRO BIOTECH, INC. (MONTCLAIR) |
22/09/2025 |
Valid |
| Optilyte Plus Analisador de Urina
81325990398 |
Urine analyzer |
II |
ACRO BIOTECH, INC. (MONTCLAIR) |
22/09/2025 |
Valid |
| Família Teste Rápido de Leptospira IgG/IgM (Sangue Total/Soro/Plasma)
81325990397 |
Leptospira spp. |
III |
HANGZHOU ALLTEST BIOTECH CO. LTD |
28/07/2025 |
Until 28/07/2035 |
| Família de Cassete de Teste para TSH (Soro/Plasma)
81325990396 |
Thyroid-stimulating hormone (TSH) - newborn screening |
III |
ACRO BIOTECH, INC. (MONTCLAIR) |
21/07/2025 |
Until 21/07/2035 |
| Família Cassete de teste de Troponina I/Mioglobina/CK-MB (3 em 1) (Sangue total/Soro/Plasma)
81325990395 |
Combined parameters in one product - class III |
III |
ACRO BIOTECH, INC. (MONTCLAIR) |
21/07/2025 |
Until 21/07/2035 |
| Família Analisador de Urina Semiautomático
81325990393 |
Urine analyzer |
II |
MACCURA MEDICAL INSTRUMENT CO., LTD. |
14/07/2025 |
Valid |
| Refrigerador farmacêutico
81325990392 |
Laboratory/hospital refrigerator or freezer |
I |
QINGDAO HAIER BIOMEDICAL CO., LTD. |
07/07/2025 |
Valid |
| Analisador de imunoensaio de Fluorescência
81325990391 |
Immunoassay instrument |
II |
ACRO BIOTECH, INC. (MONTCLAIR) |
07/07/2025 |
Valid |
| Refrigerador para banco de sangue
81325990390 |
Laboratory/hospital refrigerator or freezer |
II |
QINGDAO HAIER BIOMEDICAL CO., LTD. |
23/06/2025 |
Valid |
| Freezer de ultrabaixa temperatura para uso médico
81325990389 |
Laboratory/hospital refrigerator or freezer |
II |
QINGDAO HAIER BIOMEDICAL CO., LTD. |
23/06/2025 |
Valid |
| Família Cassete de Teste ß -hCG (Sangue Total/Soro/Plasma)
81325990388 |
Beta human chorionic gonadotropin (beta-hCG) |
II |
ACRO BIOTECH, INC. (MONTCLAIR) |
02/06/2025 |
Valid |
| Perímetro Automatizado
81325990387 |
Visual field testing instrument |
I |
FREY S.J. |
19/05/2025 |
Valid |
| Rastreador de visão
81325990386 |
Ophthalmic refractometer |
I |
HUVITZ CO LTD |
12/05/2025 |
Valid |
| Torneira de 3 vias
81325990385 |
Stopcocks |
I |
G.S.T. CORPORATION LIMITED (HEUER INTERNATIONAL) |
14/04/2025 |
Valid |
| Família Teste rápido combinado para antígeno de SARS-CoV-2/Influenza A+B/VSR/ Adenovírus/M. pneumoniae (Swab Nasofaríngeo)
81325990384 |
Combined parameters - respiratory panel |
III |
HANGZHOU ALLTEST BIOTECH CO. LTD |
20/01/2025 |
Until 20/01/2035 |
| Ensaio de Creatina Quinase MB
81325990383 |
Creatine kinase isoenzymes (CK-MB, CK-BB, CK-MM) |
III |
ACRO BIOTECH, INC. (MONTCLAIR) |
13/01/2025 |
Until 13/01/2035 |
| Kit de Teste de Amplificação de Ácido Nucléico de Papilomavírus Humano
81325990382 |
Human papillomavirus (HPV) |
III |
JIANGSU MOLE BIOSCIENCE CO., LTD. |
06/01/2025 |
Until 06/01/2035 |
| Ensaio de Proteína C-reativa
81325990381 |
High-sensitivity C-reactive protein (hs-CRP) |
II |
ACRO BIOTECH, INC. (MONTCLAIR) |
30/12/2024 |
Valid |
| Kit de extração de ácido nucleico
81325990380 |
Buffers, diluents and other solutions for laboratory analysis |
I |
JIANGSU MOLE BIOSCIENCE CO., LTD. |
23/12/2024 |
Valid |
| Rastreador de Visão
81325990379 |
Not yet published |
I |
Not yet published |
25/11/2024 |
Cancelled 27/01/2025 |
| Auto Refratômetro
81325990378 |
Ophthalmic refractometer |
I |
U.S. OPHTHALMIC LLC |
25/11/2024 |
Valid |
| Câmera de Fundo
81325990377 |
Ophthalmic camera |
I |
HUVITZ CO LTD |
14/10/2024 |
Valid |
| Tomografia de Coerência Óptica OCTAVIUS
81325990376 |
Optical coherence tomograph (OCT) |
II |
HUVITZ CO LTD |
14/10/2024 |
Valid |
| Microscópio de Lâmpada de Fenda
81325990375 |
Slit lamp |
I |
HUVITZ CO LTD |
14/10/2024 |
Valid |
| Gráfico digital
81325990374 |
Ophthalmic chart projector |
I |
HUVITZ CO LTD |
14/10/2024 |
Valid |
| Auto Refrator/Ceratômetro
81325990373 |
Ophthalmic refractometer |
I |
U.S. OPHTHALMIC LLC |
14/10/2024 |
Valid |
| Autorefrator/Ceratômetro
81325990372 |
Ophthalmic refractometer |
I |
HUVITZ CO LTD |
14/10/2024 |
Valid |
| Teste Rápido de Combo de Dengue IgG/IgM/NS1 (Sangue Total/Soro/Plasma)
81325990371 |
Not yet published |
III |
Not yet published |
07/10/2024 |
Cancelled 01/06/2026 |
| Teste Rápido de Dengue NS1 (Sangue Total/Soro/Plasma)
81325990370 |
Not yet published |
III |
Not yet published |
07/10/2024 |
Cancelled 01/06/2026 |
| Teste Rápido Dengue IgG/IgM (Sangue Total/Soro/Plasma)
81325990369 |
Not yet published |
III |
Not yet published |
07/10/2024 |
Cancelled 01/06/2026 |
| Ensaio de Antígeno de Carboidrato 199
81325990368 |
CA 19-9 antigen |
III |
ACRO BIOTECH, INC. (MONTCLAIR) |
07/10/2024 |
Until 07/10/2034 |