D3 01-085005

GUDID 30014613330691

HSV MAB CONJUGATE

DIAGNOSTIC HYBRIDS, INC.

Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, control

• Primary Device ID: 30014613330691
• NIH Device Record Key: dc2a33b7-304b-4b44-a65d-3b2417a1fb67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D3
• Version Model Number: 01-085005
• Catalog Number: 01-085005
• 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

Customer Support Contacts

• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com
• Phone: +1(858)552-1100
• Email: technicalsupport@quidel.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613330691 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K063798

FDA Product Code

• GQN: Antigen, cf (including cf control), herpesvirus hominis 1,2

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-08-22
• Device Publish Date: 2018-07-22

On-Brand Devices [D3]

• 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