ACCESS ULTRASENSITIVE INSULIN ASSAY
Device Facts
| Record ID | K953084 |
|---|---|
| Device Name | ACCESS ULTRASENSITIVE INSULIN ASSAY |
| Applicant | Bio-Rad Laboratories, Inc. |
| Product Code | CFP · Clinical Chemistry |
| Decision Date | Sep 25, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 862.1405 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An immunoreactive insulin test system is a device intended to measure immunoreactive insulin in serum and plasma. Immunoreactive insulin measurements are used in the diagnosis and treatment of various carbohydrate metabolism disorders, including diabetes mellitus, and hypoglycemia.
