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 MethodLateral Flow Chromatography (Colloidal Gold)
Test ResultQuantitative
LanguageEnglish/Chinese (Spanish, French, German, Russian, Arabic, Vietnamese etc. are under developing)
Display5.6 Inch Touch Screen; Resolution 640×480
PrinterInternal Thermal Printer
Working EnvironmentTemperature – +15¥- 35¥
Relative humidity – 10% – 85%
Air pressure – 70.0kPa – 106.0kPa”
Power SupplyAC 100 ∼ 240V, 50 ∼ 60 Hz
Data Storage10,000 results can be saved
DimensionsHeight 120mm
Width 250mm
Length 250mm
Weight1.8KG

 

Test Items

Cat.#Test ItemDiseaseMeasuring RangeSampleCut ∼ off ValueReaction Time
CG 1001Troponin I (cTnI)Myocardial Infarction0.5 ∼ 50.0ng/mlS/P/W.B0.5ng/ml15min
CG 1002NT – proBNPHeart failure100 ∼ 35000pg/mlS/P/W.B300pg/ml15min
CG 1003hs – CRPCardiovascular inflammatory diseases; Inflammatory disorders0.5 ∼ 200.0mg/LS/P/W.B/ fingertip blood3mg/L
10mg/L
90s
CG 1004NT – proBNP / cTnIHeart failure; Acute coronary syndrome100 ∼ 12000pg/ml
0.5 ∼ 50ng/ml
S/P/W.B300pg/ml
0.5ng/ml
18min
CG 1005CK – MB / cTnI / MyoMyocardial injury2.5 ∼ 80.0ng/ml
0.5 ∼ 50.0ng/ml
30 ∼ 600ng/ml
S/P/W.B5ng/ml
0.5ng/ml
70ng/ml
15min
CG 1006D – DimerVenous thromboembolism; Pulmonary embolism0.1 ∼ 10.0mg/LP/W.B0.5mg/L7min
CG 1007Procalcitonin (PCT)Sepsis; Septic shock0.1 ∼ 50ng/mlS/P/W.B0.1ng/ml15min
CG 1008CysCEarly diagnosis of kidney disease; Detection of kidney damage for surgery patients0.5 ∼ 10.0mg/LS/P/W.B0.51 ∼ 1.09 mg/L3min
CG 1009mAibEarly diagnosis and evaluation of diabetic nephropathy10 ∼ 200mg/LUrine20mg/L3min
CG 1010NGALThe best indicator of early renal injury50 ∼ 5000ng/mS/P/W.B/UrineBlood:200ng/ml
Urine:100ng/ml
10min
CG 1011β – MGKidney damage for diabetic & hypertensive patients0.5 ∼ 20.0mg/LS/P/W.B0.8 ∼ 3.0 mg/L3min
CG 1012CK – MB / cTnIMyocardinal injury2.5 ∼ 80.0ng/ml
0.5 ∼ 50.0ng/ml
S/P/W.B5ng/ml
0.5ng/ml
15min
CG 1013β HCGPregnancy early test25 ∼ 10000mIU/mlS25mIU/ml10min
CG 1017HbA1cDiabetes mellitus2% ∼ 14%W.B3.8% ∼ 5.8%3min
CG 1018CK – MBMyocardial injury2.5 ∼ 80.0ng/mlS/P/W.B5ng/ml15min
CG 1024TSHScreening, Clinical Diagnosis, Prognosis & Therapeutic Effect evaluation of Thyroid diseases0.05μIU/ml ∼ 50.00μIU/mlS/P/W.B0.27 μIU/ml ∼ 4.20 μIU/ml15min

 

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