| Primary Device ID | 00851458005099 |
| NIH Device Record Key | 8563833f-b6ca-462b-b964-293ef0e2aa07 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NGDS |
| Version Model Number | NGDS-ASY-0006 |
| Catalog Number | NGDS-ASY-0006 |
| Company DUNS | 556915205 |
| Company Name | BIOFIRE DEFENSE, LLC |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00851458005099 [Primary] |
| NSU | Instrumentation For Clinical Multiplex Test Systems |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-02 |
| Device Publish Date | 2017-04-21 |
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