ELVIS 00-011085

GUDID 30014613330165

ELVIS SOL 1, 85ML

DIAGNOSTIC HYBRIDS, INC.

Herpes simplex virus 1 & 2 (HSV1 & 2) antigen IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 30014613330165
• NIH Device Record Key: 15a6a346-6436-43eb-a149-2994f02b1cc0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELVIS
• Version Model Number: 00-011085
• Catalog Number: 00-011085
• 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	30014613330165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091753

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: 2019-03-15
• Device Publish Date: 2019-03-07

On-Brand Devices [ELVIS]

• 30014613336334: ELVIS HSV ID/TYPING TEST SYSTEM
• 30014613336327: ELVIS HSV ID/TYPING TEST SYSTEM
• 30014613336310: ELVIS STAINING KITS 500 TESTS
• 30014613336303: ELVIS STAINING KITS 200 TESTS
• 30014613336297: ELVIS STAINING KITS 1000 TESTS
• 30014613336280: ELVIS STAINING KITS 100 TESTS
• 30014613333098: ELVIS MWP W24/24F W/CS
• 30014613333081: ELVIS MWP W24/24F
• 30014613333074: ELVIS MWP W24/18F WITH CS
• 30014613333067: ELVIS MWP W24/18F
• 30014613333050: ELVIS MWP W24/12F W/CS
• 30014613333043: ELVIS MWP W24/12F
• 30014613333036: ELVIS MWP W24/10F W/CS
• 30014613333029: ELVIS MWP W24/9F
• 30014613333012: ELVIS MWP W24/8F CUST FILL
• 30014613333005: ELVIS MWP W24/8F CUST
• 30014613332992: ELVIS MWP W24/6F W/CS
• 30014613332985: ELVIS MWP W24/6F CUST FILL
• 30014613332978: ELVIS MWP W24/6F
• 30014613332961: ELVIS SV/CS
• 30014613332954: ELVIS SV WITHOUT CS
• 30014613331209: ELVIS REPLACEMENT MEDIUM
• 30014613331193: ELVIS REPLACEMENT MEDIUM
• 30014613330202: ELVIS SOL 3, 12ML
• 30014613330196: ELVIS SOL 3, 3ML
• 30014613330165: ELVIS SOL 1, 85ML
• 30014613330158: ELVIS SOL 1, 15ML
• 30014613330127: ELVIS SOL 1, 130ML
• 30014613330110: ELVIS SOL 1, 26ML
• 30014613336020: INTL-ONLY ELVIS TYPE KIT 60-TE
• 30014613336013: INTL-ONLY ELVIS STAIN KT 100TE