DensiCHEK™ CALIBRATION STANDARD

Basic Information

• Brand Name: DensiCHEK™ CALIBRATION STANDARD
• Primary DI: 03573026551155
• Version / Model: DensiCHEK™ CALIBRATION STANDARD
• Company Name: BIOMERIEUX , INC.
• Labeler DUNS: 086785110
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-12-19
• Public Version: 7
• Public Version Date: 2022-12-20
• Public Version Status: Update
• Public Device Record Key: 40051d02-e918-43e4-9167-3c1ff9f26f9d

Device Description

These are calibration standards for the DensiCHEK™ Plus instrument which is designed for use with the VITEK®2 to measure the optical density of a bacterial suspension.

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

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	03573026551155	GS1
Package	03573026103156	GS1		1	In Commercial Distribution

Premarket Submissions

Submission Number	Supplement Number
K083536	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 15 – 25 Degrees Celsius