| Primary Device ID | 03661540304286 |
| NIH Device Record Key | 8a1e3ec9-3faa-4f36-9018-a93bade35bc0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Direct A1c Control Kit |
| Version Model Number | 55136 |
| Catalog Number | 55136 |
| 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 | 03661540304286 [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 |
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| 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 |
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