| Primary Device ID | 06974849369243 |
| NIH Device Record Key | f39a31b3-311b-4e17-b4b0-64efab8ebe08 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Group B Streptococcus Nucleic Acid Detection Kit(Fluorescence PCR) |
| 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 |