AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput > 100 and <= 250 test/h)

Primary DI

06973315739580

Basic UDI-DI Code

6973315739580BG

Reference

QD-S2000

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class A

Status

On The Market

Manufacturer

Nanjing Vazyme Medical Technology Co.,Ltd.

The Automatic Fluorescence Immunoassay 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 whole human blood, serum, plasma, peripheral blood, urine, nasopharyngeal and oropharyngeal swabs. For instance, human heart fatty acid binding protein (H-FABP), N-terminal pro B-type natriuretic peptide (NT-proBNP), serum amyloid A (SAA), lipoprotein phospholipase A2 (Lp-PLA2), neutrophil gelatinase-associated lipocalin(NGAL), full-scale C-reactive protein (CRP), cardiac troponin I (cTnl), Creatine kinase MB isoenzyme (CK-MB), procalcitonin (PCT), anti-Millerian 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), human S100 protein, mycoplasma pneumoniae IgG/IgM antibody, 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 trained doctors, nurses or laboratory technicians.

Other on-the-market devices with the same classification (Eu Ivd Class A) and regulation (EU IVDR).