| Primary Device ID | 30014613330882 |
| NIH Device Record Key | 76c7c671-d3ca-4fbd-82dc-a7e39f9a1890 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D3 Duet |
| Version Model Number | 01-200000 |
| Catalog Number | 01-200000 |
| Company DUNS | 117359612 |
| Company Name | DIAGNOSTIC HYBRIDS, 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 | 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 | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30014613330882 [Primary] |
| GNW | ANTISERA, CF, INFLUENZA VIRUS A, B, C |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-03-15 |
| Device Publish Date | 2019-03-07 |
| 30014613330929 | D3 Duet DFA RSV Screening Reagent |
| 30014613330912 | D3 Duet DFA RSV Screening Reagent 2ML |
| 30014613330905 | D3 Duet DFA RSV/Respiratory Virus Screening Kit |
| 30014613330899 | D3 Duet DFA Influenza A Screening reagent |
| 30014613330882 | D3 Duet DFA Influenza A/Respiratory Virus Screening kit |