AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit

GUDID 00860006589714

AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit

Lgc Clinical Diagnostics, Inc.

Multiple respiratory virus nucleic acid IVD, control

• Primary Device ID: 00860006589714
• NIH Device Record Key: d7d6d20d-9b23-4caa-890c-0f05a59a1a47
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AccuPlex SARS-CoV-2, Flu A/B, and RSV Molecular Controls Kit
• Version Model Number: 0505-0260
• Company DUNS: 106267123
• Company Name: Lgc Clinical Diagnostics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860006589714 [Primary]

FDA Product Code

• OHQ: Multi-Analyte Controls Unassayed

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: 2023-07-25
• Device Publish Date: 2023-07-17

Devices Manufactured by Lgc Clinical Diagnostics, Inc.

• 00850075956319 - Optitrol NAT Triplex: 2026-02-09
• 00850075956326 - Optitrol NAT Triplex: 2026-02-09
• 00850075956999 - Optitrol HEPR-2: 2026-02-09
• 00850075957002 - Optitrol HEPR-2: 2026-02-09
• 00850075957033 - Optitrol Mumps M: 2026-02-09
• 00850075957040 - Optitrol Mumps M: 2026-02-09
• 00850075957057 - Optitrol Mumps M: 2026-02-09
• 00850011135846 - VALIDATE: 2026-01-14 VALIDATE pTau217 Plasma Calibration Verification / Linearity Test Kit