High Sensitivity Cardiac Marker Ck-MB Rapid Diagnostic Test

• Classification: Physiological Functions of Diagnosis and Monitoring Equipment
• Type: Urine Analyzer
• Certification: CE, FDA, ISO13485
• Group: All People
• Medical Device Regulatory Type: Type 1
• Transport Package: PP, Carton
• Model NO.: CKMB-W23
• Specification: 4.0mm
• Trademark: OEM
• Origin: China
• HS Code: 3002190090
• Production Capacity: 200000PCS/Week

Product Description

High Sensitivity Cardiac Marker Ck-MB Rapid Diagnostic Test




INTENDED USE:
The Rapid Cardiac Markers Panel test is an immunochromatography based one step in vitro test. It is designed for qualitative determination of cardiac troponin I (cTnI), CK-MB and Myoglobin in human serum, plasma or whole blood specimens as an aid in the diagnosis of myocardial infarction.

SPECIFICATION:
1) Specimen: Whole blood/serum/plasma
2) Format: Panel

FEATURE:
1) Simple: Simply add specimen and dilution(if necessary) into sample well
2) Rapid: Results come out at 15 minutes
3) Visually interpreted: Don't need any equipment
4) Stable: More than 12 month period of validity

PACKING:
Panel: 25 tests/box, 50 tests/box

ASSAY PROCEDURE:
1) Bring all materials and specimens to room temperature.
2) Remove the test card from the sealed foil pouch.
3) Place the transfer pipette in the specimen and depress the bulb to withdraw a sample.
4) Hold the pipette in a vertical position over the sample well of the test card and deliver
7-10 drops (300-500 mL) of sample into the sample well.
Note: Please deliver sample drop by drop to ensure the best performance
5) Read the result at 15 minutes.

INTERPRETATION OF RESULTS
Positive:
If two colored bands are visible on any strip of the device within 15 minutes, the test result is positive and valid. The test result can be read as soon as a distinct colored band appears in the test area.
Note: Specimens containing very low levels of cardiac markers may develop two color bands over 15 minutes.
Negative:
If test area has no color band and the control area displays a colored band, the result is negative and valid.
Invalid result:
If a colored band does not form in the control region of any strip, the test result is invalid. The sample must be re-tested, using a new test device.