ASSERACHROM HPIA TEST KIT
Device Facts
| Record ID | K003767 |
|---|---|
| Device Name | ASSERACHROM HPIA TEST KIT |
| Applicant | Diagnostica Stago, Inc. |
| Product Code | LCO · Hematology |
| Decision Date | Feb 12, 2001 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7695 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.
