ACCURUN®

GUDID 00850041090016

Lgc Clinical Diagnostics, Inc.

Multiple infectious organism/newborn TORCH screen IVD, control

• Primary Device ID: 00850041090016
• NIH Device Record Key: b69619fe-412c-4c06-a182-05404095b632
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ACCURUN®
• Version Model Number: 2010-0023
• 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: true
• 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	00850041090016 [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: 2024-08-12
• Device Publish Date: 2024-08-02

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