bCUBE bCUBE 2.0

GUDID 08057507430009

Real-time PCR instrument.

HYRIS SRL

Thermal cycler nucleic acid amplification instrument IVD, manual

• Primary Device ID: 08057507430009
• NIH Device Record Key: 0c47141f-d273-4841-83a2-2c385b42977b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: bCUBE
• Version Model Number: bCUBE 2.0
• Catalog Number: bCUBE 2.0
• Company DUNS: 441725600
• Company Name: HYRIS SRL
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057507430009 [Primary]

FDA Product Code

• NSU: Instrumentation For Clinical Multiplex Test Systems

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: 2023-03-29
• Device Publish Date: 2023-03-21

Devices Manufactured by HYRIS SRL

• 08057507430009 - bCUBE: 2023-03-29Real-time PCR instrument.
• 08057507430009 - bCUBE: 2023-03-29 Real-time PCR instrument.
• 08057507430023 - CARTUCCIA CON 16 POZZETTI/16-WELLS CARTRIDGE: 2023-03-29 PCR Cartridge.
• 08057507430030 - CARTUCCIA CON 36 POZZETTI/36-WELLS CARTRIDGE: 2023-03-29 PCR Cartridge.