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INTENDED USE
The Finecare™ HbA1c Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Hemoglobin A1c in human blood. The test is used as an aid to monitor long-term glycemic status in patients with diabetes mellitus.
STORAGE AND STABILITY
1. Store the test kit at 4℃~30℃ up to the expiration date printed on package.
2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing.
3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.
INTENDED USE
The Finecare™ HbA1c Rapid Quantitative Test is a fluorescence immunoassay used along with Finecare™ FIA System for quantitative determination of Hemoglobin A1c in human blood. The test is used as an aid to monitor long-term glycemic status in patients with diabetes mellitus.
STORAGE AND STABILITY
1. Store the test kit at 4℃~30℃ up to the expiration date printed on package.
2. If removed from refrigerator, allow the test kit for 30 minutes to return to room temperature before testing.
3. Do not remove the Test Cartridge from the pouch until use. The Test Cartridge should be used within 1 hour once opened.
SPECIFICATION
| Description | |||||
| Cat. No. | Test Item | Specimen | Reaction Time | Measuring Range | Qualification |
| W207 | HbA1c | Whole blood | 5 min | 4.0-14.5% | CE, NGSP, IFCC |
