| Primary Device ID | 03661540304675 |
| NIH Device Record Key | e540cdbb-b76a-43cb-9f9d-b07b6b32512e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Direct A1c Reagent Kit |
| Version Model Number | 55370 |
| Catalog Number | 55370 |
| Company DUNS | 052423787 |
| Company Name | ELITECHGROUP INC. |
| 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 |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com | |
| Phone | (800) 453 2725 |
| service.ebs@elitechgroup.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03661540304675 [Primary] |
| LCP | Assay, Glycosylated Hemoglobin |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-10-09 |
| Device Publish Date | 2023-10-01 |
| 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 |