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Rayto Chemray 330

Features:
  • Automatic, Random Access
  • Analytical Modes: End-point, two-point, kinetic
  • Throughput: Constant speed 200 tests per hour
  • Automatic 8-step washing system, low carry-over
  • 24 hours non-stop reagent cooling compartment
  • Sample Position: 40 positions
  • Reagent Position: 40 reagent positions in refrigerated compartment
  • Reaction Position: 81 cuvettes, 9 cuvette per strip
  • Probe: Collision protection, Liquid level detection and inventory checking

DiaSys Respons 940

Features:
  • System Type: Automated random access clinical chemistry analyzer
  • Throughput: 400 test per tests, independently for mono and two component reagents
  • Sample disk: 80 positions for samples, blanks, standards, calibrators, controls, STAT samples
  • Reagent on-board capacity: 72 reagent positions (R1+R2), refrigerated
  • Reaction Unit: 72 permanent hard glass cuvettes (37 ± 0.2°C)
  • Photometry: 12 wavelengths (340, 376, 415, 450, 480, 505, 546, 570, 600, 660, 700 and 705 nm)

Edan i15 Blood Gas and Chemistry Analyzer

Features:
  • Innovative microchip liquid control technology and micro-sensor multifunction membrane technology
  • Multi-parameter cartridge, including ABG, electrolytes and metabolites
  • Throughput: result in 1 minute after sample aspiration
  • Display: 7-inch color LCD Touch Screen Display
  • Data Storage: up to 10,000 patient results

Dengue Ag Rapid Test CE

Features:
  • In-house developed fourth generation rapid test aids in the diagnosis of an early acute infection, including primary or secondary infection
  • Detects NS1 antigen from all four dengue serotypes (DEN1, 2, 3, 4) in human serum, plasma or whole blood specimen
  • Simple assay procedure yields results within 20-25 minutes
Clinical performance:
  • Limit of Detection: detection of NS1 protein in all 4 types of dengue virus lysate I, II, III, and IV. The limit of detection is 0.25 ng/mL as determined on recombinant dengue NS1 antigen from serotype 2 (DEN2)
  • Sensitivity: 100%
  • Specificity: 98.8% comparing to a commercial ELISA
  • Cross-Reactivity: no cross-reactivity found on 6-10 positive specimens from the 21 disease states, such as chikungunya, ZIKV, malaria, leishmania, Typhoid and others
  • No interference with some common substances, such as Albumin (60 g/L), Bilirubin (20 mg/dL), Creatinine (442 µmol/L), EDTA (3.4 µmol/L), Glucose (55 mmol/L), Heparin (3,000 U/L), Salicylic acid (4.34 mmol/L), Sodium citrate (3.8%), Human IgG (1,000 mg/dL)
  • Dose Hook Effect: No hook effect was detected with dengue NS1 antigen concentration up to 200 μg/mL during the study.
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample diluent (REF SB-R0063, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0063C

Dengue Ag Rapid Test CE

30/kit

S, P &WB

Progesterone FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 0.30-80.00 ng/mL
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of PROG reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of PROG reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
PROG control materials with two different concentrations were tested by every lot of test device, and the deviations were within ± 15%.
  1. Linearity
A serial concentration of PROG reference materials at 3.00-80.00 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
  1. Specificity
Crossed Factors Concentration Test Result
Estradiol 500 ng/mL < 0.3 ng/mL
Testosterone 500 ng/mL < 0.3 ng/mL
Cortisol 500 ng/mL < 0.3 ng/mL
Aldosterone 500 ng/mL < 0.3 ng/mL
Estriol 100 ng/mL < 0.3 ng/mL
17-β Estradiol 100 ng/mL < 0.3 ng/mL
Oestrone 100 ng/mL < 0.3 ng/mL
17-α hydroxyl progesterone 100 ng/mL < 0.3 ng/mL
Reagents and Materials provided:
  1. Individually sealed foil pouches containing:
    1. One test device
    2. One desiccant
  2. Detection buffer tubes
  3. SD card
  4. Instructions for Use
Materials required but not provided:
  1. Clock or timer
  2. RaFIA Immunofluorescence Analyzer
  3. RaFIA Immunofluorescence Incubator

HSV-1 IgG/IgM Rapid Test CE

Features:
    • Type-specific detection by utilizing glycoprotein G1.
    • Single test that detects and differentiates IgG and IgM anti-HSV-1.
    • High confidence as test is in agreement with market leading ELISA test: 90.7% IgG; 85.0% IgM.
    • Flexible specimen types including serum, plasma, or whole blood which allows testing at any time without special specimen preparation.
    • Small sample volume (10 µL) enables multiple testing on the same specimen without having to re-draw the patient.
    • Initial treatment action can begin during the patient’s visit as test results are available in 10 minutes.
    • Easily transported, and can be stored for 24 months, 2-30oC.
    • Individually sealed foil pouches containing:
      • One cassette device
      • One desiccant
    • Capillary tubes (10 µL)
    • Sample diluent (REF SB-R0203, 5 mL/bottle)
    • Package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0203C

HSV-1 IgG/IgM Rapid Test CE

30/kit

S,P& WB

MAU FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES:
  • Working range: 2.0-300.0 mg/L
PRECISION:
  • Intra-lot Precision: Intra-lot precision was determined by testing of MAU reference materials using 10 test devices from the same lot. CV ≤ 15%.
  • Inter-lot Precision: Inter-lot precision was determined by testing of MAU reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY:
  • MAU control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
LINEARITY:
  • A serial concentration of MAU reference materials at 2.0-300.0 mg/L was tested, and the correlation coefficient (R) is ≥0.9900.
  • REAGENTS AND MATERIALS PROVIDED:
    1. Individually sealed foil pouches containing: a. One test device b. One desiccant
    2. Detection buffer tubes
    3. SD card
    4. Instructions for Use
    MATERIALS REQUIRED BUT NOT PROVIDED:
    1. Clock or timer
    2. RaFIA Immunofluorescence Analyzer
    3. RaFIA Immunofluorescence Incubator
CATALOG # PRODUCT QUANTITY SPECIMEN

F2020

MAU FIA Test

25/kit

Urine

CEA FIA Test

Features:
      • Quantitative, non-subjective results
      • Increased sensitivity and broader detection range compared to rapid tests
      • Range
        •  Working range: 0.5-500.0 ng/mL
        Precision  Intra-lot Precision
        •  Intra-lot precision was determined by testing of CEA reference materials using 10 test devices from the same lot.  CV ≤ 15%.
        Inter-lot Precision
        •  Inter-lot precision was determined by testing of CEA reference materials using 30 test devices from three consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
        Accuracy
        • CEA control materials with three different concentrations were tested by every lot of test device, and the deviations were within ±15%.
        Linearity
        • A serial concentration of CEA reference materials at 1-500.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900.
        Hook Effect
        •  There is no Hook effect when the level is 100000.0 ng/mL.
        Reagents and Materials provided:
        1. Individually sealed foil pouches containing:
          1.  One test device
          2.  One desiccant
        2. Detection buffer tubes
        3. SD card
        4. Instructions for Use
        Materials required but not provided:
        1. Clock or timer
        2. RaFIA Immunofluorescence Analyzer
        3. RaFIA Immunofluorescence Incubator