FIA 8000 – Quantitative Immunoassay Analyzer

65,000

FIA8000 Quantitative Immunoassay Analyzer is a medical diagnostic instrument which can be used to measure a variety of biomarkers in human whole blood, serum, plasma or other specimens. Due to its portable and light weight design, the FIA8000 can be easily deployed at patient side, facilitating the clinical decisions with its rapid results. FIA8000 offers testing of cardiac markers, inflammation monitoring, diabetes, fertility, and renal function.

SKU: CST001 Category:
Description

Application Department

The analyzer can be widely applied to clinical departments including Cardiology Dept., Clinical Laboratory, Emergency Dept., ICU, Oncology Dept., Nephrology Dept., Pediatrics Dept., Endocrinology Dept., Gynecology Dept., Respiratory Dept., Gastroenterology Dept., Urology Dept. etc.

 

Features

  • Portable Design : Small in size (250 x 250 x 120mm); Light in weight (1.8kg)
  • Multiplex Test Items : Cardiac marker; Inflammation monitoring; Diabetes; Fertility; Renal function etc.
  • Easy to Use : Ready-to-use cassette, one-step test, automatic print, quantitative result
  • Reliable Performance : CV=1%; r=0.990
  • LIS and HIS Connectivity

 

Technical Data

Assay Method Lateral Flow Chromatography (Colloidal Gold)
Test Result Quantitative
Language English/Chinese (Spanish, French, German, Russian, Arabic, Vietnamese etc. are under developing)
Display 5.6 Inch Touch Screen; Resolution 640×480
Printer Internal Thermal Printer
Working Environment Temperature – +15¥- 35¥
Relative humidity – 10% – 85%
Air pressure – 70.0kPa – 106.0kPa”
Power Supply AC 100 ∼ 240V, 50 ∼ 60 Hz
Data Storage 10,000 results can be saved
Dimensions Height 120mm
Width 250mm
Length 250mm
Weight 1.8KG

 

Test Items

Cat.# Test Item Disease Measuring Range Sample Cut ∼ off Value Reaction Time
CG 1001 Troponin I (cTnI) Myocardial Infarction 0.5 ∼ 50.0ng/ml S/P/W.B 0.5ng/ml 15min
CG 1002 NT – proBNP Heart failure 100 ∼ 35000pg/ml S/P/W.B 300pg/ml 15min
CG 1003 hs – CRP Cardiovascular inflammatory diseases; Inflammatory disorders 0.5 ∼ 200.0mg/L S/P/W.B/ fingertip blood 3mg/L
10mg/L
90s
CG 1004 NT – proBNP / cTnI Heart failure; Acute coronary syndrome 100 ∼ 12000pg/ml
0.5 ∼ 50ng/ml
S/P/W.B 300pg/ml
0.5ng/ml
18min
CG 1005 CK – MB / cTnI / Myo Myocardial injury 2.5 ∼ 80.0ng/ml
0.5 ∼ 50.0ng/ml
30 ∼ 600ng/ml
S/P/W.B 5ng/ml
0.5ng/ml
70ng/ml
15min
CG 1006 D – Dimer Venous thromboembolism; Pulmonary embolism 0.1 ∼ 10.0mg/L P/W.B 0.5mg/L 7min
CG 1007 Procalcitonin (PCT) Sepsis; Septic shock 0.1 ∼ 50ng/ml S/P/W.B 0.1ng/ml 15min
CG 1008 CysC Early diagnosis of kidney disease; Detection of kidney damage for surgery patients 0.5 ∼ 10.0mg/L S/P/W.B 0.51 ∼ 1.09 mg/L 3min
CG 1009 mAib Early diagnosis and evaluation of diabetic nephropathy 10 ∼ 200mg/L Urine 20mg/L 3min
CG 1010 NGAL The best indicator of early renal injury 50 ∼ 5000ng/m S/P/W.B/Urine Blood:200ng/ml
Urine:100ng/ml
10min
CG 1011 β – MG Kidney damage for diabetic & hypertensive patients 0.5 ∼ 20.0mg/L S/P/W.B 0.8 ∼ 3.0 mg/L 3min
CG 1012 CK – MB / cTnI Myocardinal injury 2.5 ∼ 80.0ng/ml
0.5 ∼ 50.0ng/ml
S/P/W.B 5ng/ml
0.5ng/ml
15min
CG 1013 β HCG Pregnancy early test 25 ∼ 10000mIU/ml S 25mIU/ml 10min
CG 1017 HbA1c Diabetes mellitus 2% ∼ 14% W.B 3.8% ∼ 5.8% 3min
CG 1018 CK – MB Myocardial injury 2.5 ∼ 80.0ng/ml S/P/W.B 5ng/ml 15min
CG 1024 TSH Screening, Clinical Diagnosis, Prognosis & Therapeutic Effect evaluation of Thyroid diseases 0.05μIU/ml ∼ 50.00μIU/ml S/P/W.B 0.27 μIU/ml ∼ 4.20 μIU/ml 15min

 

Here is the list of references for FIA 8000 – Quantitative Immunoassay Analyzer
FIA 8000 brochure View
Declaration of Conformity - CE8000 View
ISO 13485:2012/AC:2012 - Year 2016 View
NGSP - Certificate of Traceability View