| Primary Device ID | B652IB793050 |
| NIH Device Record Key | b5383c24-f437-42dd-a2c9-41eb37b19933 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Salivary Cortisol ELISA |
| Version Model Number | IB79305 |
| 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | +1(888) 523-1246 |
| info@ibl-america.com | |
| Phone | +1(888) 523-1246 |
| info@ibl-america.com |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B652IB793050 [Primary] |
| NHG | Enzyme Immunoassay, Cortisol, Salivary |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-11-26 |
| Device Publish Date | 2018-10-26 |
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| 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 | 2018-11-26Enzyme Immunoassay for the quantitative determination of cortisol in saliva. |
| B652IB793050 - Salivary Cortisol ELISA | 2018-11-26 Enzyme Immunoassay for the quantitative determination of cortisol in saliva. |