bCUBE

Basic Information

• Brand Name: bCUBE
• Primary DI: 08057507430009
• Version / Model: bCUBE 2.0
• Catalog Number: bCUBE 2.0
• Company Name: HYRIS SRL
• Labeler DUNS: 441725600
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-03-21
• Public Version: 1
• Public Version Date: 2023-03-29
• Public Version Status: New
• Public Device Record Key: 0c47141f-d273-4841-83a2-2c385b42977b

Device Description

Real-time PCR instrument.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
NSU	Instrumentation For Clinical Multiplex Test Systems	Clinical Chemistry	862.2570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
48032	Thermal cycler nucleic acid amplification instrument IVD, manual	An electrically-powered laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen using heat-stable polymerase enzymes and cycles of repeated heating and cooling (i.e., thermal cycling) to replicate a product [i.e., a polymerase chain reaction (PCR)]. The instrument may also isolate, extract and/or prepare nucleic acid from a clinical specimen prior to amplification and the characterization of amplified product may occur separately following the amplification process using electrophoresis genetic-based probes or other investigative methods. The device operates with technician involvement in most procedural steps.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08057507430009	GS1