| Primary Device ID | 06974849369281 |
| NIH Device Record Key | e8dcca5d-6d1c-420c-8ae8-c3412744648f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nucleic Acid Detection Kit based on Enzymatic Probe Isothermal Amplification (EP |
| Version Model Number | 50 tests/kit |
| Company DUNS | 560300737 |
| Company Name | Jiangsu Macro & Micro-Test Med-Tech Co., Ltd. |
| 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 | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |