Uncut sheet for Blood Quantity Myoglobin Myo FIA Rapid test
1. INTEDED USE
This product is a myoglobin (Myo) fluorescence immunochromatography uncut sheet (semi-finished IVD intermediate) , designed for the quantitative in vitro determination of myoglobin in human serum, plasma, or whole blood samples.
Myoglobin is an early biomarker of myocardial injury. The test results may aid in the adjunctive diagnosis of acute myocardial infarction (AMI) and acute coronary syndrome (ACS).
Product Type: Semi-finished uncut sheet (intermediate), for further manufacturing and IVD kit assembly only. Not for direct clinical use.
Storage: Dry at 2–30°C, protected from light.
2. PRODUCT SPECIFICATION
| Model No. | Myoglobin Uncut sheet |
| Methodology | Fluorescence Immune analyzer |
| 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
|
3.TEST METHOD
| 1 | Slowly draw 80µL of serum/plasma/whole blood samples at a time. Be cautious not to draw bubbles. |
| 2 | Add the drawn sample to sample diluent. Mix the sample and the sample diluent sufficiently; |
| 3 | Pipette 80µL of the mixed solution to sample hole of the test device. During sampling, be cautious not to draw bubbles. |
4.Why choose Uncut Sheet
1.High Cost-Effectiveness For the mass production.
2.Excellent Stability and Convenient Storage
3.Customizable and Strongly Adaptable
4.High Accuracy Low Error
5. CERTIFICATE
* ISO System Certificate
* CE Certificate
* EU Registration
* UCKA MHRA Registration






