DensiCHEK™ Plus Standards

Basic Information

• Brand Name: DensiCHEK™ Plus Standards
• Primary DI: 03573026222222
• Version / Model: 21255
• Company Name: BIOMERIEUX , INC.
• Labeler DUNS: 086785110
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-11-30
• Public Version: 7
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 767654ff-bba5-4640-9a67-9abba5c76ba8

Device Description

These are calibration standards for the DensiCHEK™ Plus instrument. This instrument is uses with the VITEK®2 to measure the optical density of bacterial suspensions.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• 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

GMDN Terms

Code	Name	Definition	Implantable	Status
58049	Optical laboratory instrument performance standard calibrator/control IVD, reusable	A solid phase or liquid reference standard 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). It is typically presented as a solid/sealed cuvette or a multiple-well test plate and may include filters or a light source emitted at specified wavelengths. Verification/optimization functions may include optical density (absorbance/scattering), fluorescent or luminescent accuracy, linearity, repeatability and/or limit of detection readings, and optical alignment and precision of the instrument/analyser. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03573026222222	GS1

Premarket Submissions

Submission Number	Supplement Number
K083536	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 5 – 30 Degrees Celsius