| Primary Device ID | 08809319396161 |
| NIH Device Record Key | f6f7301f-53c3-4bcf-95cc-53c6b280d592 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CURO L7 Analyzer |
| Version Model Number | 99LA10G-2 |
| Company DUNS | 557812789 |
| Company Name | SD Biosensor, 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 | true |
| 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 | true |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08809319396161 [Primary] |
| NBW | System, Test, Blood Glucose, Over The Counter |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2020-05-12 |
| Device Publish Date | 2020-04-21 |
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| 00887473000313 - STANDARD™ LipidoCare Lipid Test Strip - Lipid Profile | 2023-03-27 |
| 08809319396161 - CURO L7 Analyzer | 2020-05-12 |
| 08809319396161 - CURO L7 Analyzer | 2020-05-12 |
| 00887473000009 - SD GlucoNavii Blood Glucose Monitoring System | 2018-07-06 |
| 00887473000016 - SD GlucoNavii Blood Glucose Monitoring System | 2018-07-06 |
| 00887473000108 - SD GlucoNavii Blood Glucose Monitoring System | 2018-07-06 |
| 0887473000115 - SD GlucoNavii Blood Glucose Test Strip | 2018-07-06 |