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TB IgG/IgM Combo Rapid Test CE

  Features: A lateral flow chromatographic immunoassay for the simultaneous detection and differentiation of IgM and IgG anti-Mycobacterium tuberculosis (anti-M. TB)  in human serum, plasma or whole blood.
  • Individually sealed foil pouches containing:
    • One cassette device
    • One desiccant
  • Plastic droppers
  • Sample diluent (REF SB-R0053, 5 mL/bottle)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0053C

TB IgG/IgM Combo Rapid Test CE

30/kit

S, P &WB

COVID-19 + Influenza A/B Ag Rapid Test CE

Features:
  • Aids in identifying SARS-CoV-2, Influenza A, and Influenza B infection, within the first seven days of symptom onset.
  • Differentiates 3 infections in 1 test.
  • Efficiently tests for 3 infections with only 1 patient sample.
  • Easy to use, minimal training required, no lab equipment needed.
  • All-in-one package for point-of-care use and resource-limited settings.
  • Results in 15 minutes.
  • Reagents and Materials Provided:
    1. Individually sealed foil pouches containing:
      1. Two cassettes assembled into one panel
      2. One desiccant
    2. Sample extraction tubes
    3. Sample extraction tube rack
    4. Sample extraction buffer (REF SB-R0188, 5 mL/bottle)
    5. Nozzles with filter
    6. Individually sealed pouches containing a sterile swab
    7. Instructions for Use
    Materials Required but Not Provided:
    • Clock or timer
    Materials May be Required but Not Provided:
    • Positive control
    • Negative Control
    • Nasal Swabs
CATALOG # PRODUCT QUANTITY SPECIMEN

R0188C

COVID-19 + Influenza A/B Ag Rapid Test CE

15/kit

Swab

Medica EasyLyte PLUS (Na+/K+/Cl-) Medica EasyLyte Calcium (Na+/K+/Ca++/pH) Medica EasyLyte Expand (Na+/K+/Cl-/Ca++)

Features:
  • Method: Direct measurement by Ion Selective Electrode (ISE)
  • Calibration: Automatic or On-demand
  • Sample Type: Whole Blood, Serum, Plasma or Urine
  • Sample Size: 100μl Whole Blood, Serum, Plasma
400μl diluted Urine (1:10)

FOB Rapid Test CE

Features:
  • Designed to specifically detect low levels of fecal occult blood, hHB ≥ 50 ng/mL
  • Higher accuracy, sensitivity and specificity than the Guaiac Test
  • No dietary restrictions
  • Clear, easy-to-interpret result
  • Individually sealed foil pouches containing:
    • One cassette test device.
    • One desiccant
  • Stool collection devices, each containing 2 mL of extraction buffer (REF SB-R2010)
  • Patient ID stickers
  • One package insert (instruction for use)
  • CATALOG # PRODUCT QUANTOTY SPECIMEN

    R2010C

    FOB Rapid Test

    25/kit

    Fecal

HbA1c FIA Test

  Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
RANGES
  • Working range: 4%–15%
PRECISION
  • Intra-lot Precision Intra-lot precision was determined by testing of HbA1c reference materials using 10 test devices from the same lot. CV ≤ 15%
  • Inter-lot Precision Inter-lot precision was determined by testing of HbA1c reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
ACCURACY
  • HbA1c 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 HbA1c reference materials at 4%–15% 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

F6100

HbA1c FIA Test

25/kit

Serum, Plasma

Strep A Rapid Test (strip) CE

Features:
  • High confidence as test has no cross-reactivity with 22 common organisms
  • Convenient all-in-one package designed for use at point of care that requires minimal training
  • Safe for patients as it includes a CE marked high-quality reliable swab
  • Comfortable to handle with an ergonomic, user-friendly extraction tube that minimizes contamination
  • Initial patient care action can begin during the patient’s visit as results are available within 5 minutes
  • Individually sealed foil pouches containing:
    • One strip device
    • One desiccant
  • Sample extraction tubes
  • Sterile swabs, each sealed in a plastic-paper pouch
  • Extraction Reagent A (REF SB-R0184A,10 mL/bottle)
  • Extraction Reagent B (REF SB-R0184B,10 mL/bottle)
  • Strep A Positive Control (200 µL/vial)
  • Strep A Negative Control (200 µL/vial)
  • One package insert (instruction for use)
CATALOG # PRODUCT QUANTITY SPECIMEN

R0184S

Strep A Rapid Test (strip) CE

25/kit

Swab

Hemaray 51

Features:
  • 30 parameters including 4 research parameters, 3 scattergrams and 3 histograms
  • Tri-angular laser scatter + Flow cytometry for 5-partWBC counting
  • Independent BASO counting channel
  • 4 TFT Colored LCD with Touch Screen
  • Throughput: 60 samples per hour
  • Sample Type: Whole Blood, Peripheral Blood, Pre-diluted Blood
  • Built-in Thermal printer
  • Data Storage: 100,000 sample results

tPSA FIA Test

Features:
  • Quantitative, non-subjective results
  • Increased sensitivity and broader detection range compared to rapid tests
  1. Range
Working range: 0.5-200.0 ng/mL
  1. Precision
Intra-lot Precision Intra-lot precision was determined by testing of tPSA reference materials using 10 test devices from the same lot. CV ≤ 15%. Inter-lot Precision Inter-lot precision was determined by testing of tPSA reference materials using 30 test devices from 3 consecutive lots randomly (10 test devices from each lot). CV ≤ 20%.
  1. Accuracy
tPSA 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 tPSA reference materials at 0.5-200.0 ng/mL was tested, and the correlation coefficient (R) is ≥ 0.9900. 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