| Primary Device ID | B652IB59109 |
| NIH Device Record Key | 240c3227-11b1-4170-9cc9-42f07c2e3fe0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Testosterone (Free) ELISA |
| Version Model Number | IB59109 |
| Company DUNS | 159853449 |
| Company Name | IBL America |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | false |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| B652IB59105 - Estrone ELISA | 2023-06-16 For the quantitative measurement of Estrone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). |
| B652IB59107 - Pregnenolone ELISA | 2023-06-16 For the quantitative measurement of Pregnenolone in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). |
| B652IB59109 - Testosterone (Free) ELISA | 2023-06-16Enzyme immunoassay (ELISA) for the direct quantitative determination of Free Testosterone in human serum. |
| B652IB59109 - Testosterone (Free) ELISA | 2023-06-16 Enzyme immunoassay (ELISA) for the direct quantitative determination of Free Testosterone in human serum. |
| B652IB59110 - Prolactin ELISA | 2023-06-16 For the quantitative determination of Prolactin in human serum by an enzyme immunoassay. |
| B652IB59134 - Total Estrogens ELISA | 2023-06-16 Enzyme immunoassay (ELISA) for the quantitative determination of Total Estrogens in human serum. |
| B652IB793050 - Salivary Cortisol ELISA | 2018-11-26 Enzyme Immunoassay for the quantitative determination of cortisol in saliva. |