| Primary Device ID | 06973342000530 |
| NIH Device Record Key | 07753f87-f786-4f63-9601-875f437c763e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | COVID-19 Coronavirus Real Time PCR Kit |
| Version Model Number | 25 Tests |
| Company DUNS | 548535842 |
| Company Name | Jiangsu Bioperfectus Technologies Co., Ltd. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| 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 | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 06973342000530 [Primary] |
| QQX | Respiratory Specimen Nucleic Acid Sars-Cov-2 Test |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-10 |
| Device Publish Date | 2023-02-02 |
| 06973342000110 - Nucleic Acid Extraction System | 2023-02-10 |
| 06973342000189 - Nucleic Acid Extraction System | 2023-02-10 |
| 06973342000219 - Nucleic Acid Extraction System | 2023-02-10 |
| 06973342000240 - Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method) | 2023-02-10 |
| 06973342000257 - Real-time PCR System | 2023-02-10 |
| 06973342000530 - COVID-19 Coronavirus Real Time PCR Kit | 2023-02-10 |
| 06973342000530 - COVID-19 Coronavirus Real Time PCR Kit | 2023-02-10 |
| 06973342000547 - Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method) | 2023-02-10 |
| 06973342000554 - Nucleic Acid Extraction Rapid Kit (Magnetic Bead Method) | 2023-02-10 |