Quantum Dot Fluorescence Immune Analyzer

Primary DI

06973315739566

Basic UDI-DI Code

6973315739566BN

Reference

QD-S600

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Nanjing Vazyme Medical Technology Co.,Ltd.

This Quantum Dot Fluorescence Immune Analyzer is an in vitro diagnostic medical device, which intended to be used with the fluorescence immunoassay kits produced by Nanjing Vazyme Medical Technology Co., Ltd. The analyzer is designed for the quantitative, semi-quantitative, or qualitative determination of samples in human whole blood, serum, plasma, peripheral blood, urine, nasopharyngeal and oropharyngeal swabs. For instance, heart-type fatty acid-binding protein (h-FABP), n-terminal brain natriuretic peptide (NT-proBNP), serum amyloid A (SAA), lipoprotein phospholipase A2 (Lp-PLA2), neutrophil gelatinaseassociated lipocalin(NGAL), full-scale c-reactive protein (CRP), cardiac troponin I (cTnl), creatine kinase isoenzymes (CK-MB), procalcitonin (PCT), anti-Müllerian hormone (AMH), d-dimer, hemoglobin A1c (HbA1c), pepsinogen I (PG I), pepsinogen II (PG II), gastrin-17 (G-17), myeloperoxidase (MPO), high sensitivity cardiac troponin T(hs-cTnT), brain natriuretic peptide (BNP), anti-PLA2R (IgG), interleukin 6 (IL-6), 25-hydroxy Vitamin D ((25-(OH))D), S100, mycoplasma pneumoniae antibody (IgG), mycoplasma pneumoniae antibody (IgM), respiratory syncytial virus/adenovirus/parainfluenza virus antigens, and influenza A and B antigens. The test results are used as a clinical aid for diagnosis, and are intended to be read by medical laboratory professionals or by trained doctors, nurses or laboratory technicians.

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