Calmark COVID19-LDH Point-of-Care Diagnostic System

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Calmark COVID19-LDH Point-of-Care Diagnostic System is a portable instrument combined with a single-use test measuring LDH in whole blood in patients diagnosed with the SARS-CoV-2 virus.
● Minimum Order Quantity (MOQ): 1 device
● Seller Name: Calmark
● Seller Location: Sweden
● Warranty Term: 1 year
● Regulatory Approvals: CE; ISO 13485

SKU: VIA_CalmarkCL Categories: , Tag:

Additional information

Weight 2 kg
Dimensions 21 × 16 × 30 cm

Description

Calmark COVID19-LDH Point-of-Care Diagnostic System consist of a portable instrument, the Calmark POC-Analyzer, combined with Calmark COVID19-LDH Test Cassettes. The system is used for measuring the concentration of LDH in whole blood in patients diagnosed with the SARS-CoV-2 virus, and providing faster results compared to currently available blood tests. Only a few drops of blood are needed. The analysis can take place wherever the patient is located, eg. in an emergency room. The result is presented on the display after only 2.5 minutes, which reduces both costs and time.

LDH has been identified as an important biomarker for predicting the severity of COVID-19 infection. Multiple published studies show that if elevated LDH levels can be detected at an early stage, there is a greater chance to identify patients at risk, predict the severity and begin clinical intervention and monitoring.

The COVID19-LDH POC System is adapted for hospital environments and is intended for in vitro diagnostics.

Key Features

Usability
Rapid, safe, and easy measurement of LDH concentration in whole blood of patients diagnosed with the SARS-CoV-2 virus. Optimized for accurate analysis with just a few drops of whole blood. Results are presented after 2.5 minutes as a numeric value on the display of the instrument. Time and cost saving.

Flexible & Portable
Battery indication and capacity of eight working hours, charged with micro-USB connector, charger included. Storage and memory function with 25 results stored locally in the instrument.

Accurate
A detection range of 180-350 U/L (3-5,8 µkat/L). High tolerance for hemolysis and accurate results at up to 52% hematocrit.

The LDH level is sensitive to temperature, hence the measurement should be done in a room temperature between 19-26°C. A thermometer is provided with the instrument as an accessory.

Quality Design
Unique design, easy to handle. The POC-Analyzer is calibrated during manufacturing. Each test cassette contains information needed for automatic calibration of the results; no recalibration needed.

Specifications

Instrument Measurements

  • Dimensions: 120 x 93 x 210 mm (W x H x D)
  • Net weight: 0.9 kg

Test Cassette Measurements

  • Dimensions: 23.2 x 42.1 x 8.7 mm (W x H x D)
  • Net weight: 2.79 g

Performance COVID19-LDH Test

  • Detection range: 180-350 U/L (3-5.8 µkat/L)
  • Accuracy <180 U/L (3 µkat/L): 13.3%
  • Accuracy 180-350 U/L (3-5.8 µkat/L): 10.4%
  • Accuracy >350 U/L (5.8 µkat/L): 7.7%
  • Measurement time: 2.5 minutes

Power

  • Battery: Powered by a Li-Ion battery
  • Charger: Micro-USB connection (USB-adapter provided) (CE-approved, In 100-240V AC/50-60Hz<500mA, out 5V DC)

Operating Environment

  • Temperature: 19-26°C (66.2-78.8 F)
  • Humidity: 20-80% RH

Transportation and Storage

  • Temperature: 10-40˚C (50-104 F)
  • Humidity: 10-90% RH

Standard Accessories

  • Battery charger and adapter (1x)
  • Thermometer (1x)
  • COVID19-LDH test cassettes (20x)

Optional Accessories & Add-ons

Product Documents, Manuals & Brochures

Brochure

User Manual

Specifications

Whitepaper

Regulatory Certificates

ISO 13485

Free Sales Certificate

Declaration of Conformity - CE Mark

Videos

FAQ

Not available at this time

 

Studies & Trials

Not available at this time

 

Package Contents

  • 1x POC-Analyzer COVID19-LDH Main Unit
  • 1x Battery charger
  • 1x Thermometer
  • 20x COVID19-LDH Test Cassettes (1x pack)

Warranty

The POC-Analyzer has 12 months of warrant from delivery of the product. Contact your VIA sales representative if you have any issues with the product.

Testimonials

Not available at this time

 

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