| Primary Device ID | 30014613330431 |
| NIH Device Record Key | 69c1b2a6-8388-4259-aabb-9f6f9bdc2a13 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D3 Ultra |
| Version Model Number | 01-013402.V2 |
| Catalog Number | 01-013402.V2 |
| 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 | false |
| 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 |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com | |
| Phone | +1(858)552-1100 |
| technicalsupport@quidel.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30014613330431 [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 |
| 30014613330479 | Parainfluenza 3 DFA Reagent |
| 30014613330462 | Parainfluenza 2 DFA Reagent |
| 30014613330455 | Parainfluenza 1 DFA Reagent |
| 30014613330431 | Adeno DFA Reagent |
| 30014613330424 | RSV DFA Reagent |
| 30014613330417 | Influenza B DFA Reagent |
| 30014613330394 | Influenza A DFA Reagent |
| 30014613330387 | Influenza A DFA Reagent-BULK |
| 30014613330370 | DFA Respiratory Virus Screening Reagent |
| 30014613330363 | DFA Respiratory Virus Screening Reagent - Bulk |
| 30014613330356 | D3 Ultra DFA Respiratory Virus ID Set |
| 30014613330349 | D3 Ultra DFA Parainfluenza Reagent Set |
| 30014613330325 | De Ultra DFA Influenza A/Influenza B Reagent Set |
| 30014613330318 | D3 Ultra DFA RSV Reagent Set |
| 30014613330301 | D3 Ultra DFA Respiratory Virus Shell Vial Screening Set |
| 30014613330295 | D3 Ultra DFA Respiratory Virus Direct Specimen Screening set |
| 30014613330288 | D3 Ultra DFA Respiratory Virus Screening and ID kit |