| Primary Device ID | 06438147355037 |
| NIH Device Record Key | e4c988d9-14c6-442b-97af-00a995cf70a4 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | AutoDELFIA Unconjugated Estriol (uE3) kit |
| Version Model Number | B095-112 |
| Catalog Number | B095-112 |
| Company DUNS | 540156544 |
| Company Name | Wallac Oy |
| 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 | true |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06438147355037 [Primary] |
| CGI | Radioimmunoassay, Estriol |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-12-17 |
| Device Publish Date | 2018-11-16 |
| 06438147355037 | Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3) |
| 06438147355013 | Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3) |
| 06438147119745 | Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3) |
| 06438147119332 | Time-resolved fluoroimmunoassay for the quantitative determination of unconjugated estriol (uE3) |