MicroVue A018

GUDID 30014613335566

MicroVue CH50 Eq EIA

QUIDEL CORPORATION

Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA) Total complement activity (CH50) IVD, kit, enzyme immunoassay (EIA)

• Primary Device ID: 30014613335566
• NIH Device Record Key: 4129bd91-ebe5-4946-af08-6bd4982ab68b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MicroVue
• Version Model Number: CH50 Eq EIA
• Catalog Number: A018
• Company DUNS: 079509836
• Company Name: QUIDEL CORPORATION
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	30014613335566 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K974111

FDA Product Code

• DAE: COMPLEMENT C9, ANTIGEN, ANTISERUM, CONTROL

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-15

On-Brand Devices [MicroVue]

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• 30014613335573: Kit, Quidel Bb Plus
• 30014613335566: MicroVue CH50 Eq EIA
• 30014613335559: MicroVue CIC-C1q Ctrls
• 30014613335542: MicroVue CIC-Raji EIA
• 30014613335535: MicroVue CIC-C1q EIA
• 30014613333951: MicroVue Vitamin D EIA
• 30014613333944: MicroVue PTH EIA
• 30014613333937: MicroVue Calcitonin EIA
• 30014613333920: MicroVue BAP EIA
• 30014613333913: Kit, McVu PYD
• 30014613333906: Kit, McVu DPD