Uncut sheet for Free Thyroxine FT4 Test
1. INTEDED USE
This kit is applicable to in vitro quantitative detection of free thyroxine (FT4) in human serum/plasma/whole blood sample, which’s mainly used for assessment of thyroid function. This kit only provides free thyroxine (FT4) test results, and results obtained shall be used in combination with other clinical information for analysis. It must only be used by healthcare professionals.
2. PRODUCT SPECIFICATION
| Model No. | FT4 Uncut sheet |
| Methodology | fluorescence immunochromatographic assay |
| Sample Type | Serum,Plasma,Whole blood |
| Time to Result | 15~20mins |
| Storage | 2~30 ℃/36~86℉ |
| Shelf Life | 24 months |
| Certificate | ISO13485, CE Certificate, UCKA MHRA Certificate |
|
Feature • High sensitive • result reading in 15-20 minutes • Easy operation • High Accuracy |
PACKING * 20 bags /CTN * Aluminum foil bag labeling * shrink wrap
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3.TEST METHOD
| 1 | Open the aluminum foil bag package of reagent and take out the test device. |
| 2 | Horizontally insert the test device into the slot of immune analyzer. |
| 3 | On home page of operation interface of immune analyzer, click “Standard” to enter test interface. |
| 4 | Click “QC Scan” to scan the QR code on inner side of the kit; input kit related parameters into instrument and select sample type. Note: Each batch number of the kit shall be scanned for once. If the batch number has been scanned, then skip this step. |
| 5 | Check the consistency of “Product Name”, “Batch Number” etc. on test interface with information on the kit marker. |
| 6 | After information consistency is confirmed, take out sample diluents, add 80µL of serum/plasma/whole blood sample, and mix well |
| 7 | Add 80µL of above mixed solution into the sample hole of test device. |
| 8 | After complete sample addition, click “Timing” and remaining test time will be automatically displayed on the interface. |
| 9 | Immune analyzer will automatically complete test and analysis when test time is reached. |
| 10 | Ⅰ-2: Result calculation and display After the test by immune analyzer is completed, test result will be displayed on test interface or can be viewed through “History” on home page of operation interface. |
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration










