ELVIS 55-2424S

GUDID 30014613333098

ELVIS MWP W24/24F W/CS

DIAGNOSTIC HYBRIDS, INC.

Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD Cell culture line IVD

• Primary Device ID: 30014613333098
• NIH Device Record Key: b1dc443b-3159-49af-96a0-1f985772a3c5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ELVIS
• Version Model Number: 55-2424S
• Catalog Number: 55-2424S
• 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

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
• 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
• 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	30014613333098 [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: 2018-09-07
• Device Publish Date: 2018-08-07

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