COLUMNMATE(TM) BETA-THAL CAT. NO. 4515
Device Facts
| Record ID | K913384 |
|---|---|
| Device Name | COLUMNMATE(TM) BETA-THAL CAT. NO. 4515 |
| Applicant | Helena Laboratories |
| Product Code | JPD · Hematology |
| Decision Date | Dec 17, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7400 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A hemoglobin A2 assay is a device used to determine the hemoglobin A2 content of human blood. The measurement of hemoglobin A2 is used in the diagnosis of the thalassemias (hereditary hemolytic anemias characterized by decreased synthesis of one or more types of hemoglobin polypeptide chains).
