| Primary Device ID | 04051839002914 |
| NIH Device Record Key | d9ccb738-bea7-415c-8c0b-5ebe4552a0c8 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | β-Hydroxybutyrate 21 Tri-Level Controls |
| Version Model Number | 595709943085 |
| Catalog Number | 595709943085 |
| Company DUNS | 328419718 |
| Company Name | DiaSys Diagnostic Systems GmbH |
| 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 | 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 | 04051839002914 [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 | 2018-11-29 |
| Device Publish Date | 2018-10-29 |
| 04051839002891 - β-Hydroxybutyrate 21 FS | 2018-12-17 For the quantitative determination of beta-hydroxybutyrate in human serum or plasma. |
| 04051839002907 - β-Hydroxybutyrate 21 FS | 2018-12-17 For the quantitative determination of beta-hydroxybutyrate in human serum or plasma. |
| 04051839002921 - β-Hydroxybutyrate 21 Bi-Level Controls | 2018-12-17 For use as controls in quantative procedures for β-Hydroxybutyrate |
| 04051839002938 - β-Hydroxybutyrate 21 Linearity Standards | 2018-12-17 For use as linearity standards in quantitative procedures for β-Hydroxybutyrate |
| 04051839002914 - β-Hydroxybutyrate 21 Tri-Level Controls | 2018-11-29For use as controls in quantitative procedures for β-Hydroxybutyrate |
| 04051839002914 - β-Hydroxybutyrate 21 Tri-Level Controls | 2018-11-29 For use as controls in quantitative procedures for β-Hydroxybutyrate |