ACCURUN® 2020-0155

GUDID 00850041090047

ACCURUN Babesia Molecular Controls Kit

Lgc Clinical Diagnostics, Inc.

Babesia microti nucleic acid IVD, control

• Primary Device ID: 00850041090047
• NIH Device Record Key: c5438eb1-6baa-4359-a225-3e9430148ae2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCURUN®
• Version Model Number: 2020-0155
• Catalog Number: 2020-0155
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850041090047 [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: 2023-10-30
• Device Publish Date: 2023-10-20

On-Brand Devices [ACCURUN®]

• 00850041090047: ACCURUN Babesia Molecular Controls Kit
• 00860006589790: 0505-0300
• 00860006589776: 2000-0079
• 00860006589707: 2000-0080
• 00850041090122: 2020-0185
• 00850041090115: 2020-0164
• 00850041090108: 2000-0107
• 00850041090092: 2000-0106
• 00850041090085: 2010-0026
• 00850041090078: 2010-0025
• 00850041090061: 2000-0105
• 00850041090054: 2020-0162
• 00850041090030: 2000-0102
• 00850041090023: 2015-0240
• 00850041090016: 2010-0023
• 00850041090009: 2000-0101
• 00816784021007: 2000-0071
• 00816784020864: 0505-0220
• 00816784020741: 2000-0079
• 00816784020734: 0505-0242
• 00816784020086: 0505-0227