| QUANTA Link
80003619006 |
Not yet published |
II |
Not yet published |
30/12/2019 |
Cancelled 30/09/2024 |
| HEMOHUB
80003619005 |
Software |
II |
INSTRUMENTATION LABORATORY CO. |
29/10/2019 |
Valid |
| GEMWEB PLUS 500
80003619004 |
Software |
II |
INSTRUMENTATION LABORATORY CO. |
26/08/2019 |
Valid |
| Nova View - Microscópio IFA automatizado
80003619003 |
Sample preparation and processing instrument - pre-analytical phase |
I |
INOVA DIAGNOSTICS, INC. |
11/03/2013 |
Valid |
| Spiro-ball Exercitador Volumétrico
80003619002 |
Not yet published |
I |
Not yet published |
26/03/2012 |
Cancelled 27/09/2021 |
| Tri-ball Exercitador Respiratório
80003619001 |
Not yet published |
I |
Not yet published |
12/03/2012 |
Cancelled 27/09/2021 |
| HemosIL Chromogenic Factor
80003610628 |
Coagulation factor IX |
II |
INSTRUMENTATION LABORATORY |
05/10/2026 |
Valid |
| Família GEM System Evaluator
80003610627 |
Combined parameters in one product - class III |
III |
INSTRUMENTATION LABORATORY |
27/07/2026 |
Until 27/07/2036 |
| MATCH IT! Platelet Antibody
80003610626 |
IVD software |
I |
IMMUCOR GTI DIAGNOSTICS, INC |
08/06/2026 |
Valid |
| MATCH IT! Antibody
80003610625 |
IVD software |
I |
IMMUCOR GTI DIAGNOSTICS, INC |
18/05/2026 |
Valid |
| MatchX
80003610624 |
IVD software |
II |
IMMUCOR GTI DIAGNOSTICS, INC |
12/01/2026 |
Valid |
| Luminex®100/200™ Performance Verification Kit
80003610623 |
Solution for performance testing of equipment components |
I |
LUMINEX CORPORATION |
03/11/2025 |
Valid |
| Família Luminex® 200™
80003610622 |
Flow cytometer |
II |
LUMINEX CORPORATION |
03/11/2025 |
Valid |
| Luminex® 100/200™ Calibration Kit
80003610621 |
Solution for performance testing of equipment components |
I |
LUMINEX CORPORATION |
24/10/2025 |
Valid |
| GEM Premier 7000 com iQM3
80003610620 |
Combined parameters in one product - class III |
III |
INSTRUMENTATION LABORATORY |
20/10/2025 |
Until 20/10/2035 |
| xMAP® Sheath Fluid PLUS
80003610619 |
Flow cytometry - ancillary reagents |
I |
LUMINEX CORPORATION |
15/09/2025 |
Valid |
| FLEXMAP 3D® Calibration Kit
80003610618 |
Solution for performance testing of equipment components |
I |
LUMINEX CORPORATION |
15/09/2025 |
Valid |
| FLEXMAP 3D® Performance Verification Kit
80003610617 |
Solution for performance testing of equipment components |
I |
LUMINEX CORPORATION |
15/09/2025 |
Valid |
| FLEXMAP 3D®
80003610616 |
Flow cytometer |
II |
LUMINEX CORPORATION |
08/09/2025 |
Valid |
| GEM Premier 7000
80003610615 |
Analyzer for blood gases, ions or pH |
II |
INSTRUMENTATION LABORATORY |
07/04/2025 |
Valid |
| Família QUANTA Flash HMGCR
80003610614 |
3-Hydroxy-3-methylglutaryl-coenzyme A reductase (HMGCR or HMG-CoA reductase) |
II |
INOVA DIAGNOSTICS, INC |
17/02/2025 |
Valid |
| Família QUANTA Flash Circulating Calprotectin
80003610613 |
Calprotectin |
II |
INOVA DIAGNOSTICS, INC |
17/02/2025 |
Valid |
| ACL TOP 970 CL
80003610612 |
Hemostasis analyzer |
II |
INSTRUMENTATION LABORATORY |
06/01/2025 |
Valid |
| Família ACL TOP Série 70
80003610611 |
Hemostasis analyzer |
II |
INSTRUMENTATION LABORATORY |
06/01/2025 |
Valid |
| Família Hemochron Jr. Citrate Prothrombin Time (PT)
80003610610 |
Prothrombin time (PT) |
III |
ACCRIVA DIAGNOSTICS INC. |
19/02/2024 |
Until 19/02/2034 |
| Família Hemochron Jr. Citrate Activated Partial Thromboplastin Time (APTT)
80003610609 |
Activated partial thromboplastin time (aPTT) |
III |
ACCRIVA DIAGNOSTICS INC. |
19/02/2024 |
Until 19/02/2034 |
| DCJCPT-N- directCHECK Normal Controls - Citrate PT - APTT
80003610608 |
Activated partial thromboplastin time (aPTT) |
III |
ACCRIVA DIAGNOSTICS INC. |
19/02/2024 |
Until 19/02/2034 |
| NOVA Lite DAPI dsDNA Crithidia luciliae Kit
80003610607 |
Antinuclear antibody (ANA) |
II |
INOVA DIAGNOSTICS, INC |
29/09/2022 |
Valid |
| Família Plastic Capillaries for Blood Gas
80003610606 |
Container or material for collection, storage or transport of biological samples |
I |
SC - SANGUIS COUNTING KONTROLLBLUTHERSTELLUNGS- UND VERTRIEBS GMBH |
20/04/2022 |
Valid |
| Família GEM Hemochron 100 ACT
80003610605 |
Activated clotting time (ACT) |
III |
ACCRIVA DIAGNOSTICS INC. |
10/01/2022 |
Until 10/01/2032 |
| Família GEM Hemochron 100 ACT-LR
80003610604 |
Activated clotting time (ACT) |
III |
ACCRIVA DIAGNOSTICS INC. |
10/01/2022 |
Until 10/01/2032 |
| GEM Hemochron
80003610603 |
Hemostasis analyzer |
II |
ACCRIVA DIAGNOSTICS INC. |
16/12/2021 |
Valid |
| Família NOVA Lite DAPI EMA Kit
80003610602 |
Celiac disease antibody |
II |
INOVA DIAGNOSTICS, INC. |
02/09/2021 |
Valid |
| Família ACL Elite
80003610601 |
Hemostasis analyzer |
II |
INSTRUMENTATION LABORATORY COMPANY |
22/04/2021 |
Valid |
| Família HemosIL AcuStar Anti-Cardiolipin IgG
80003610600 |
Anticardiolipin |
II |
INSTRUMENTATION LABORATORY CO. |
17/12/2020 |
Valid |
| Família HemosIL AcuStar Anti-Cardiolipin IgM
80003610599 |
Anticardiolipin |
II |
INSTRUMENTATION LABORATORY CO. |
17/12/2020 |
Valid |
| HemosIL AcuStar Von Willebrand Factor Collagen Binding Activity
80003610598 |
Von Willebrand factor |
II |
BIOKIT S/A
BIOKIT SA |
17/12/2020 |
Valid |
| HemosIL AcuStar Von Willebrand Factor Ristocetin Cofactor Activity
80003610597 |
Von Willebrand factor |
II |
INSTRUMENTATION LABORATORY CO. |
17/12/2020 |
Valid |
| HemosIL AcuStar Von Willebrand Factor Antigen
80003610596 |
Von Willebrand factor |
II |
INSTRUMENTATION LABORATORY CO. |
17/12/2020 |
Valid |
| HemosIL AcuStar HIT-IgG (PF4-H)
80003610595 |
Anti-platelet antibody |
II |
INSTRUMENTATION LABORATORY CO. |
12/11/2020 |
Valid |
| HemosIL AcuStar HIT Controls
80003610594 |
Heparin |
II |
INSTRUMENTATION LABORATORY CO. |
12/11/2020 |
Valid |
| Família ChemSTAT Hematocrit Evaluator
80003610593 |
Blood cell count |
II |
INSTRUMENTATION LABORATORY CO. |
29/10/2020 |
Valid |
| Família GEM ChemSTAT PVP
80003610592 |
Combined parameters in one product - class II |
II |
INSTRUMENTATION LABORATORY CO. |
29/10/2020 |
Valid |
| Família GEM ChemSTAT CVP 3 e 4
80003610591 |
Creatinine |
II |
INSTRUMENTATION LABORATORY CO. |
29/10/2020 |
Valid |
| Família GEM ChemSTAT critPVP
80003610590 |
Combined parameters in one product - class II |
II |
INSTRUMENTATION LABORATORY CO. |
29/10/2020 |
Valid |
| Família ChemSTAT System Evaluator
80003610589 |
Combined parameters in one product - class II |
II |
INSTRUMENTATION LABORATORY CO. |
22/10/2020 |
Valid |
| Família GEM ChemSTAT CVP 1 e CVP 2
80003610588 |
Combined parameters in one product - class II |
II |
INSTRUMENTATION LABORATORY CO. |
01/10/2020 |
Valid |
| GEM Premier ChemSTAT PAK
80003610587 |
Combined parameters in one product - class III |
III |
INSTRUMENTATION LABORATORY CO. |
28/09/2020 |
Until 28/09/2030 |
| GEM Premier ChemSTAT PAK
80003610586 |
Combined parameters in one product - class III |
III |
INSTRUMENTATION LABORATORY CO. |
28/09/2020 |
Until 28/09/2030 |
| Família HemosIL Dabigatran
80003610585 |
Thrombin inhibitor |
II |
INSTRUMENTATION LABORATORY CO. |
21/09/2020 |
Valid |