cTnI/CK-MB/Myo Rapid Quantitative Test
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INTENDED USE
The Finecare™ One Step cTn I/CK-MB/Myo Rapid Quantitative Test a fluorescence immunoassay to be used along with Finecare™ FIA System for quantitative determination of cardiac Troponin I (cTn I), MB Isoenzyme of Creatine Kinase (CK-MB) and Myoglobin (Myo) in human whole blood, serum or plasma. The test is used as an aid to the diagnosis of myocardial infarction.
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STORAGE AND STABILITY
1. Store Finecare™ One Step cTn I/CK-MB/Myo Rapid Quantitative Test at 4 ℃~30 ℃. Do not freeze. Shelf life is up to 24 months, refer to label for expiration date
2. If removed from refrigeration, allow the Test Cartridge for 30 minutes to reach room temperature (25±2℃) before testing. 3. Once opened, commence to use the Test Cartridge within an hour.
4. Do not remove the device from the pouch until ready to use. Keep the Test Cartridges away from light.
SPECIFICATION
| Description |
| Cat. No. |
Test Item |
Specimen |
Reaction Time |
Measuring Range |
Qualification |
| W216 |
cTnI/CK-MB/Myo |
Serum/Plasma/Whole Blood |
15 min |
cTnI: 0.1-50ng/mL
Myo: 2.0-400ng/mL
CK-MB: 0.3-100ng/mL |
CE |
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