A-GENT QUANTICHROM THROMBIGEN-E
Device Facts
| Record ID | K800656 |
|---|---|
| Device Name | A-GENT QUANTICHROM THROMBIGEN-E |
| Applicant | Abbott Laboratories |
| Product Code | GGQ · Hematology |
| Decision Date | May 30, 1980 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.7720 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A prothrombin consumption tests is a device that measures the patient's capacity to generate thromboplastin in the coagulation process. The test also is an indirect indicator of qualitative or quantitative platelet abnormalities. It is a screening test for thrombocytopenia (decreased number of blood platelets) and hemophilia A and B.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
