Exicycler™ 384 A-2061

GUDID 08809537070751

Bioneer Corporation

Thermal cycler nucleic acid amplification analyser IVD, laboratory, automated

• Primary Device ID: 08809537070751
• NIH Device Record Key: daa4e61c-2724-48b2-9c16-ebdb01ddf4a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exicycler™ 384
• Version Model Number: A-2061
• Catalog Number: A-2061
• Company DUNS: 688014216
• Company Name: Bioneer Corporation
• 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: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08809537070751 [Primary]

FDA Product Code

• OOI: Real Time Nucleic Acid Amplification System

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: 2021-07-30
• Device Publish Date: 2021-07-22

Devices Manufactured by Bioneer Corporation

• 08809537078412 - Exicycler™ V5 96: 2024-09-17
• 08809537078429 - Exicycler™ V5 96 Fast: 2024-09-17
• 08809537078436 - Exicycler™ V5 384: 2024-09-17
• 08809537078443 - Exicycler™ V5 384 Fast: 2024-09-17
• 08809357174134 - ExiPrep™ Dx Viral RNA Kit: 2022-09-12 96 test/kit
• 08809357174158 - ExiPrep™ Dx Viral DNA/RNA Kit: 2022-09-12 96 test/kit
• 08809357174172 - ExiPrep™ Dx Viral DNA Kit: 2022-09-12 96 test/kit
• 08809357174196 - ExiPrep™ Dx Blood Genomic DNA Kit: 2022-09-12 96 test/kit