| Primary Device ID | 30014613330837 |
| NIH Device Record Key | cec0f7b0-470d-4dbc-9b4b-ce6662f4d469 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D3 Fastpoint |
| Version Model Number | 01-120002.B2 |
| Catalog Number | 01-120002.B2 |
| 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 | 30014613330837 [Primary] |
| LKT | RESPIRATORY SYNCYTIAL VIRUS, ANTIGEN, ANTIBODY, IFA |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-08-22 |
| Device Publish Date | 2018-07-22 |
| 30014613330875 | L-DFA Parainfluenza Virus/Adenovirus Reagent |
| 30014613330868 | L-DFA RSV/MPV Reagent |
| 30014613330851 | L-DFA Influenza A/Influenza B Reagent |
| 30014613330844 | Re-Suspension Buffer |
| 30014613330837 | FASTPOINT RSV/MPV KIT BX 2 |
| 30014613330820 | FASTPOINT RSV/MPV KIT BX 1 |
| 30014613330813 | D3 FASTPOINT RSV/MPV KIT |
| 30014613330806 | FASTPOINT FLUA/B KIT BX 2 |
| 30014613330790 | FASTPOINT FLUA/B KIT BX 1 |
| 30014613330783 | FASTPOINT FLUA/B KIT |
| 30014613330776 | D3 FASTPOINT LDFA VIR IDKIT BX |
| 30014613330769 | D3 FASTPOINT LDFA VIR IDKIT BX |
| 30014613330752 | D3 FASTPOINT RESP VIRUS ID KIT |
| 30014613338727 | L-DFA RSV/MPV Antigen Control Slides |
| 30014613338710 | L-DFA Influenza A/Influenza B Antigen Control Slides |