| Controle I – cTnT, CK-MB e Myo
82533950152 |
Combined parameters in one product - class III |
III |
ZYBIO INC. |
09/02/2026 |
Until 09/02/2036 |
| Controle I – cTnI, CK-MB e Myo
82533950151 |
Combined parameters in one product - class III |
III |
ZYBIO INC. |
02/02/2026 |
Until 02/02/2036 |
| Controle I – IL-6
82533950150 |
Interleukins |
II |
ZYBIO INC. |
12/01/2026 |
Valid |
| Diluente H58 DR
82533950149 |
Buffers, diluents and other solutions for laboratory analysis |
I |
ZYBIO INC. |
12/01/2026 |
Valid |
| Diluente H58 DN
82533950148 |
Buffers, diluents and other solutions for laboratory analysis |
I |
ZYBIO INC. |
12/01/2026 |
Valid |
| Lise H58 LS
82533950147 |
Lysis solution |
I |
ZYBIO INC. |
12/01/2026 |
Valid |
| Lise H58 LN
82533950146 |
Lysis solution |
I |
ZYBIO INC. |
12/01/2026 |
Valid |
| Lise H58 LD
82533950145 |
Lysis solution |
I |
ZYBIO INC. |
12/01/2026 |
Valid |
| us-cTnI (imunofluorescência)
82533950144 |
Troponin |
III |
ZYBIO INC. |
05/01/2026 |
Until 05/01/2036 |
| Troponina T (Imunofluorescência)
82533950143 |
Troponin |
III |
ZYBIO INC. |
05/01/2026 |
Until 05/01/2036 |
| Troponina I (Imunofluorescência)
82533950142 |
Troponin |
III |
ZYBIO INC. |
05/01/2026 |
Until 05/01/2036 |
| BNP (Imunofluorescência)
82533950141 |
Human brain natriuretic peptide (BNP) |
III |
ZYBIO INC. |
29/12/2025 |
Until 29/12/2035 |
| Controle I – T4
82533950140 |
Thyroxine (T4) |
II |
ZYBIO INC. |
22/12/2025 |
Valid |
| Controle I – TSH
82533950139 |
Thyroid-stimulating hormone (TSH) |
II |
ZYBIO INC. |
22/12/2025 |
Valid |
| Controle I – Proteína C Reativa/ Proteína Amiloide A Sérica
82533950138 |
Combined parameters in one product - class II |
II |
ZYBIO INC. |
22/12/2025 |
Valid |
| Controle I – HbA1c
82533950137 |
Glycated hemoglobin (HbA1c) |
II |
ZYBIO INC. |
22/12/2025 |
Valid |
| Adesivo CGM
82533950136 |
Surgical and adhesive tapes |
I |
SHENZHEN SISENSING CO., LTD. |
15/12/2025 |
Valid |
| Controle I - PCT
82533950135 |
Procalcitonin (PCT) |
III |
ZYBIO INC. |
08/12/2025 |
Until 08/12/2035 |
| Controle I - NT-proBNP
82533950134 |
Human brain natriuretic peptide (BNP) |
III |
ZYBIO INC. |
08/12/2025 |
Until 08/12/2035 |
| HbA1c (imunofluorescência)
82533950133 |
Glycated hemoglobin (HbA1c) |
II |
ZYBIO INC. |
01/12/2025 |
Valid |
| Controle I – T3
82533950132 |
Triiodothyronine (T3) |
II |
ZYBIO INC. |
01/12/2025 |
Valid |
| T3 livre (Imunofluorescência)
82533950131 |
Free triiodothyronine (FT3) |
II |
ZYBIO INC. |
01/12/2025 |
Valid |
| Controle I – 25-hidroxivitamina D
82533950130 |
25-Hydroxyvitamin D3 (vitamin D) |
II |
ZYBIO INC. |
24/11/2025 |
Valid |
| AMH (Imunofluorescência)
82533950129 |
Anti-Müllerian hormone (AMH) |
II |
ZYBIO INC. |
24/11/2025 |
Valid |
| Procalcitonina (Imunofluorescência)
82533950128 |
Procalcitonin (PCT) |
III |
ZYBIO INC. |
17/11/2025 |
Until 17/11/2035 |
| PSA
82533950127 |
Prostate-specific antigen (PSA) |
III |
QINGDAO HIGHTOP BIOTECH CO.,LTD. |
10/11/2025 |
Until 10/11/2035 |
| Dímero D (Imunofluorescência)
82533950126 |
D-dimer |
III |
ZYBIO INC. |
03/11/2025 |
Until 03/11/2035 |
| NT-proBNP (Imunofluorescência)
82533950125 |
Human brain natriuretic peptide (BNP) |
III |
ZYBIO INC. |
03/11/2025 |
Until 03/11/2035 |
| SAA (Imunofluorescência)
82533950124 |
Serum amyloid A (SAA) |
II |
ZYBIO INC. |
03/11/2025 |
Valid |
| T4 livre (Imunofluorescência)
82533950123 |
Free thyroxine (FT4) |
II |
ZYBIO INC. |
03/11/2025 |
Valid |
| mALB (Imunofluorescência)
82533950122 |
Albumin |
II |
ZYBIO INC. |
03/11/2025 |
Valid |
| cTnT, CK-MB e Myo (Imunofluorescência)
82533950121 |
Combined parameters in one product - class III |
III |
ZYBIO INC. |
20/10/2025 |
Until 20/10/2035 |
| Sistema de Monitoramento Contínuo de Glicose GS1 Eco
82533950120 |
Interstitial fluid glucose monitoring (percutaneous) - sensor/transmitter |
III |
SHENZHEN SISENSING CO., LTD. |
13/10/2025 |
Until 13/10/2035 |
| TSH (Imunofluorescência)
82533950119 |
Thyroid-stimulating hormone (TSH) |
II |
ZYBIO INC. |
15/09/2025 |
Valid |
| Interleucina 6 (Imunofluorescência)
82533950118 |
Interleukins |
II |
ZYBIO INC. |
15/09/2025 |
Valid |
| Proteína C Reativa (Imunofluorescência)
82533950117 |
C-reactive protein (CRP) |
II |
ZYBIO INC. |
15/09/2025 |
Valid |
| T4 (Imunofluorescência)
82533950116 |
Thyroxine (T4) |
II |
ZYBIO INC. |
08/09/2025 |
Valid |
| T3 (Imunofluorescência)
82533950115 |
Triiodothyronine (T3) |
II |
ZYBIO INC. |
08/09/2025 |
Valid |
| 25-hidroxivitamina D (Imunofluorescência)
82533950114 |
25-Hydroxyvitamin D3 (vitamin D) |
II |
ZYBIO INC. |
08/09/2025 |
Valid |
| SIBIONICS Proview
82533950113 |
IVD software |
I |
SHENZHEN SISENSING CO., LTD. |
21/07/2025 |
Valid |
| Adesivo CMG
82533950112 |
Surgical and adhesive tapes |
I |
SHENZHEN SISENSING CO., LTD. |
30/06/2025 |
Valid |
| Frasco de Hemocultura (Anaeróbio)
82533950111 |
Culture media and devices for both primary inoculation and clinical specimen transport |
I |
ZYBIO INC. |
12/05/2025 |
Valid |
| Frasco de Hemocultura (Aeróbio)
82533950110 |
Culture media and devices for both primary inoculation and clinical specimen transport |
I |
ZYBIO INC. |
05/05/2025 |
Valid |
| Família Sistema de Hemocultura EXB
82533950109 |
Blood culture system (microorganism growth detection) |
II |
ZYBIO INC. |
05/05/2025 |
Valid |
| Flu A + Flu B Ag
82533950108 |
Combined parameters in one product - class III |
III |
QINGDAO HIGHTOP BIOTECH CO.,LTD. |
28/04/2025 |
Until 28/04/2035 |
| Sistema de Monitoramento Contínuo GS1
82533950107 |
Interstitial fluid glucose monitoring (percutaneous) - sensor/transmitter |
III |
SHENZHEN SISENSING CO., LTD. |
31/03/2025 |
Until 31/03/2035 |
| COVID-19 + Flu A + Flu B
82533950106 |
Combined parameters - respiratory panel |
III |
QINGDAO HIGHTOP BIOTECH CO.,LTD. |
31/03/2025 |
Until 31/03/2035 |
| Flu A e B + COVID-19 + RSV Ag
82533950105 |
Combined parameters - respiratory panel |
III |
QINGDAO HIGHTOP BIOTECH CO.,LTD. |
24/02/2025 |
Until 24/02/2035 |
| RSV Ag
82533950104 |
Respiratory syncytial virus (RSV) |
II |
QINGDAO HIGHTOP BIOTECH CO.,LTD. |
27/01/2025 |
Valid |
| Família de Medidores de Glicose
82533950103 |
Self-test instrument for glucose |
III |
TIANJIN EMPECS MEDICAL DEVICE CO. LTD |
16/12/2024 |
Until 16/12/2034 |