| Primary Device ID | 03661540300035 |
| NIH Device Record Key | 2e57dda3-b80a-4fd9-b7c8-c27cffc54cc3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Microsed-System® Automated ESR Analyzer |
| Version Model Number | PRD-MSS-EL-08TKNE |
| Catalog Number | PRD-MSS-EL-08TKNE |
| Company DUNS | 052423787 |
| Company Name | ELITECHGROUP INC. |
| 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 | false |
| Serial Number | true |
| Manufacturing Date | true |
| 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 |
| 03661540300035 - Microsed-System® Automated ESR Analyzer | 2023-10-09The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative determination of erythrocyte sedimentation rate (ESR) in human whole blood samples by laboratory professionals. Elevated ESR results indicate degrees of inflammation or disease present in the human body. |
| 03661540300035 - Microsed-System® Automated ESR Analyzer | 2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de |
| 03661540300042 - Mix-Rate® X20 Automated ESR Analyzer | 2023-10-09 The ESR analyzer is an automated, microprocessor controlled, in vitro diagnostic device that is intended for the quantitative de |
| 03661540300202 - Monosed® ESR Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300219 - Monosed® ESR Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300240 - Excyte® ESR Non-Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300257 - Excyte® ESR Vacuum Tubes, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300264 - Excyte® ESR Vacuum Tube, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |
| 03661540300271 - Excyte® ESR Vacuum Tube, Carton | 2023-10-09 ESR Tubes are single use devices intended to be used as whole blood sample tubes for the quantitative determination of Erythrocy |