Optitrol HEPR-2

GUDID 00850075956999

Lgc Clinical Diagnostics, Inc.

Multiple blood-borne virus antigen/antibody IVD, control

• Primary Device ID: 00850075956999
• NIH Device Record Key: fb26db65-9571-473e-9f1e-df1ef3f65c89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Optitrol HEPR-2
• Version Model Number: SR12055
• Company DUNS: 106267123
• Company Name: Lgc Clinical Diagnostics, 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: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850075956999 [Primary]

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: 2026-02-09
• Device Publish Date: 2026-01-30

On-Brand Devices [Optitrol HEPR-2]

• 00850075957002: SR12057
• 00850075956999: SR12055