Definition: The HS Salivary Cortisol Enzyme Immunoassay Kit Is For The Quantitative In Vitro Diagnostic Measurement Of Salivary Cortisol. This Kit May Be Used To Measure Adrenal Cortical Function And As A Screen For Cushing's And Addison's Disease. This Kit Is N
| Device Type ID | 634 |
| Device Name | Enzyme Immunoassay, Cortisol, Salivary |
| Regulation Description | Cortisol (hydrocortisone And Hydroxycorticosterone) Test System. |
| Regulation Medical Specialty | Clinical Chemistry |
| Review Panel | Clinical Chemistry |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR) |
| Submission Type | 510(k) |
| CFR Regulation Number | 862.1205 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NHG |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 634 |
| Device | Enzyme Immunoassay, Cortisol, Salivary |
| Product Code | NHG |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cortisol (hydrocortisone And Hydroxycorticosterone) Test System. |
| CFR Regulation Number | 862.1205 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TECAN GROUP AG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Incorrect Or Inadequate Test Results | 5 |
High Test Results | 4 |
Device Ingredient Or Reagent | 1 |
| Total Device Problems | 10 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Tecan US, Inc. | II | Aug-24-2018 |