Clearview®

GUDID 10815845020048

ALERE SAN DIEGO, INC.

Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, rapid ICT, clinical

• Primary Device ID: 10815845020048
• NIH Device Record Key: 9d176f31-00aa-4a2d-bc4b-428f09856c14
• Commercial Distribution Discontinuation: 2021-01-21
• Commercial Distribution Status: Not in Commercial Distribution
• Brand Name: Clearview®
• Version Model Number: 92405
• Company DUNS: 194854949
• Company Name: ALERE SAN DIEGO, INC.
• Device Count: 30
• 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: true
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx
• Phone: (866) 216-0094
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
GS1	00815845020041 [Unit of Use]
GS1	10815845020048 [Primary]

FDA Product Code

• LYR: Helicobacter Pylori

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: 2024-06-13
• Device Publish Date: 2016-09-24

On-Brand Devices [Clearview®]

• 10815845020024: 92002
• 10815845020000: 92401
• 10815845020048: 92405