| Primary Device ID | 05415168004763 |
| NIH Device Record Key | a30aa747-137c-486c-ac61-bc311adf2073 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Alpha2-Macroglobulin Serum CONT KIT |
| Version Model Number | 08240426190 |
| Catalog Number | 08240426190 |
| Company DUNS | 374384030 |
| Company Name | Diagam |
| Device Count | 1 |
| DM Exempt | false |
| 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 | true |
| 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 | 05415168004763 [Primary] |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-01-16 |
| Device Publish Date | 2020-01-08 |
| 05415168006873 - Alpha2-macroglobulin | 2021-12-15 In vitro diagnostic reagent for the quantitative determination of alpha2macroglobulin in samples of human origin (serum, heparin |
| 05415168003476 - Alpha2-Macroglobulin | 2020-01-16 Quantitative determination of Alpha2-Macroglobulin in human serum and heparinised plasma on cobas c501/502 systems. |
| 05415168004763 - Alpha2-Macroglobulin Serum CONT KIT | 2020-01-16Assayed control for Alpha2-Macroglobulin assay on cobas c501/502 systems. |
| 05415168004763 - Alpha2-Macroglobulin Serum CONT KIT | 2020-01-16 Assayed control for Alpha2-Macroglobulin assay on cobas c501/502 systems. |
| 05415168004770 - Alpha2-Macroglobulin CAL KIT | 2020-01-16 Calibration of Alpha2-Macroglobulin assay on cobas c501/502 systems. |