Primary Device ID | 30014613330875 |
NIH Device Record Key | 545618cb-56b6-43a0-afd1-31d70fb744a1 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | D3 Fastpoint |
Version Model Number | 01-123504 |
Catalog Number | 01-123504 |
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 | 30014613330875 [Primary] |
GNY | ANTISERA, FLUORESCENT, ADENOVIRUS 1-33 |
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 |
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 |