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.
DensiCHEK™ CALIBRATION STANDARD - DensiCHEK™ CALIBRATION STANDARD
Device Description
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.
Environmental Conditions
- 25.00
- 15.00
Device Sizes
No Data Available
Device Sterilization
Device Sterile: False
Sterilization Prior To Use: False
Sterilization Methods: No Data Available
Product Codes
Code: LON
Device Name: System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
Device Class: 2
Physical State: N/A
Definition: N/A
Submission Type ID: 1
Review Panel: MI
Review Code: N/A
Technical Method: N
Gmp Exempt Flag: N/A
Life Sustain Support Flag: N
Unclassified Reason: N/A
Implant Flag: N
Target Area: N/A
Regulation Number: 866.1645
Third Party Flag: N
Medical Specialty: MI
Device IdentifiersDevice Id: 03573026551155
Device Type: Primary
DeviceId Issuing Agency: GS1
Contains DI Number: N/A
Package Quantity: N/A
Package Discontinue Date: N/A
Package Status: N/A
Package Type: N/A
Device Id: 03573026103156
Device Type: Package
DeviceId Issuing Agency: GS1
Contains DI Number: 03573026551155
Package Quantity: 1
Package Discontinue Date: N/A
Package Status: In Commercial Distribution
Package Type: N/A