Colibri Daily Verification Kit

Basic Information

• Brand Name: Colibri Daily Verification Kit
• Primary DI: 08050148218005
• Version / Model: WR090-01-0004
• Catalog Number: WR090-01-0004
• Company Name: COPAN WASP SRL
• Labeler DUNS: 434263590
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 2
• Record Status: Published
• Publish Date: 2022-11-15
• Public Version: 5
• Public Version Date: 2024-01-31
• Public Version Status: Update
• Public Device Record Key: ee2e81a5-48e2-4f59-9dd2-609f7174a999

Device Description

Colibri Daily Verification Kit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	866.1645	2
QBN	Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	866.3378	2
QQV	Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry	Microbiology	866.3378	2

GMDN Terms

Code	Name	Definition	Implantable	Status
58048	Optical laboratory instrument performance standard calibrator/control IVD, single-use	A reference standard solution or soluble substance of known optical and physical characteristics intended to be used to verify and/or optimise the performance of an optical laboratory instrument (e.g., spectrophotometer, nephelometer, microplate reader, PCR instrument, flow cytometer). Verification/optimization functions may include optical density (absorbance/scattering), fluorescent/luminescent accuracy and compensation, linearity at specified wavelengths and/or stray light interference. It may be used to verify pipetting/dispensing/aspiration/diluting functions using spectrophotometry/nephelometry to determine concentration/residual volume. Solutions may be single or short-term use.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08050148218005	GS1
Unit of Use	58050148218000	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]