| Primary Device ID | 05400569000483 |
| NIH Device Record Key | bce1875e-652f-4b32-8f27-fd590fefa3f2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | PRL-IRMA |
| Version Model Number | KIP1441 |
| Company DUNS | 458777323 |
| Company Name | Diasource Immunoassays S.A. SA |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| 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 | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 05400569000483 [Primary] |
| CFT | RADIOIMMUNOASSAY, PROLACTIN (LACTOGEN) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-23 |
| Device Publish Date | 2020-01-15 |
| 05400569000674 - Estrone-RIA-CT | 2020-09-24 Estrone-RIA-CT |
| 05400569000360 - E2 RIA CT | 2020-09-23 E2 RIA CT |
| 05400569000650 - 11-DESOXYCORTISOL-RIA-CT | 2020-09-23 11-DESOXYCORTISOL-RIA-CT |
| 05400569000049 - C-PEP-EASIA | 2020-09-22 C-PEP-EASIA |
| 05400569000377 - FSH IRMA | 2020-09-22 FSH IRMA |
| 05400569000865 - Androstenedione-ELISA | 2020-09-22 Androstenedione-ELISA |
| 05400569000209 - IGF-1 ELISA | 2020-09-21 IGF-1 ELISA |
| 05400569000414 - KIP1131 | 2020-09-21 Urinary hGH IRMA |