| Primary Device ID | 30014613338550 |
| NIH Device Record Key | e548320c-da15-48d9-9368-62009fbcb5d2 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | D3 |
| Version Model Number | 20-4750010 |
| Catalog Number | 20-4750010 |
| Company DUNS | 117359612 |
| Company Name | DIAGNOSTIC HYBRIDS, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 30014613338550 [Primary] |
| OHQ | Multi-analyte controls unassayed |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-04-29 |
| Device Publish Date | 2019-04-19 |
| 30014613330738 | HSV-2 MAB CONJUGATE |
| 30014613330721 | HSV-1 MAB CONJUGATE |
| 30014613330714 | DFA HSV TYPING REAGENT DUO PK |
| 30014613330707 | D3 DFA HSV ID AND TYPING KIT |
| 30014613330691 | HSV MAB CONJUGATE |
| 30014613330684 | D3 DFA HERPES SIMPLEX ID KIT |
| 30014613330677 | CMV IEA MAB CONJUGATE |
| 30014613330660 | D3 DFA Cytomegalovirus ID Kit |
| 30014613330639 | Anti- Mouse Conjugate - Bulk |
| 30014613330622 | Anti-Mouse Conjugate |
| 30014613330615 | ENTERO MAB REAGENT 500ML |
| 30014613330608 | Enterovirus Reagent |
| 30014613330592 | EV MAB CONJUGATE |
| 30014613330585 | D3 Enterovirus Duo Pack |
| 30014613330578 | Enterovirus Reagent BULK 1 LITER |
| 30014613330561 | D3 IFA Enterovirus Identification Kit |
| 30014613330554 | CTMAB CONJUGATE |
| 30014613330547 | D3 DFA CHLM CULT CONF KIT |
| 30014613330530 | MPV MAB CONJUGATE |
| 30014613330523 | MPV/DFA REAGENT 2ML |
| 30014613330516 | MPV DFA KIT |
| 30014613330509 | VZV DFA REAGENT |
| 30014613330493 | D3 DFA Varicella-zoster Virus Kit |
| 30014613330448 | D3 DFA 500 ML SCR REAGENT |
| 30014613330400 | Influenza B DFA Reagent-BULK |
| 30014613330271 | Mounting Fluid (15mL) (pH 7.0-7.4) |
| 30014613330257 | 40X Wash Solution Concentrate |
| 30014613330240 | RSV Antigen Control Slides |
| 30014613330233 | CMV Antigen Control Slide |
| 30014613338703 | CMV Antigen Control Slides |
| 30014613338697 | Chlamydia Antigen Control Slides |
| 30014613338680 | hMPV Antigen Control Slides |
| 30014613338673 | VZV Antigen Control Slides |
| 30014613338666 | HSV-1/HSV-2 Antigen Control Slides |
| 30014613338642 | Respiratory Virus Antigen Control Slides (8 well slide, 7 viruses, 1 negative well) |
| 30014613338611 | CMV Control Stock |
| 30014613338604 | HSV-2 Control Stock |
| 30014613338598 | HSV-1 Control Stock |
| 30014613338581 | hMPV Virus Control Stock |
| 30014613338574 | Parainfluenza 3 Virus Control Stock |
| 30014613338567 | Parainfluenza 2 Virus Control Stock |
| 30014613338550 | Parainfluenza 1 Virus Control Stock |
| 30014613338543 | Adenovirus Control Stock |
| 30014613338536 | RSV Virus Control Stock |
| 30014613338529 | Influenza B Virus Control Stock |
| 30014613338512 | Influenza A Virus Control Stock |
| 30014613338505 | Respiratory Control Stock |
| 30014613338499 | VZV Control Stock (Single Use) (shipped frozen) |
| 30014613338482 | Chlamydia trachomatis, LGV Strain |
| 30014613330950 | DOUBLE DUET RESPIRATORY KIT |