| Primary Device ID | 04051839013682 |
| NIH Device Record Key | 6169950f-97d6-4a81-ae01-8bd34638c6cd |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TruCal Procalcitonin Calibrator Set |
| Version Model Number | 173109943082 |
| Catalog Number | 173109943082 |
| Company DUNS | 328419718 |
| Company Name | DiaSys Diagnostic Systems GmbH |
| 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 | 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 | false |
| OTC Over-The-Counter | false |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
| 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 |
|---|---|
| GS1 | 04051839013682 [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 | 2025-08-11 |
| Device Publish Date | 2025-08-01 |
| 04051839013668 - DiaSys Procalcitonin FS | 2025-08-11 Diagnostic reagent for quantitative in vitro determination of procalcitonin (PCT) in human serum or lithium heparin plasma |
| 04051839013675 - TruLab Procalcitonin Bi-Level Controls | 2025-08-11 TruLab Procalcitonin Bi-Level Controls are an assayed quality control material for monitoring the performance of quantitative in |
| 04051839013682 - TruCal Procalcitonin Calibrator Set | 2025-08-11The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay |
| 04051839013682 - TruCal Procalcitonin Calibrator Set | 2025-08-11 The TruCal Procalcitonin Calibrator Set is intended for in vitro use for calibration of the DiaSys Procalcitonin FS assay |
| 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 | 2018-11-29 For use as controls in quantitative procedures for β-Hydroxybutyrate |