AccessGUDID - DEVICE: DensiCHEK™ CALIBRATION STANDARD (03573026551155)

GUDID

Device Identifier (DI) Information

Brand Name: DensiCHEK™ CALIBRATION STANDARD
Version or Model: DensiCHEK™ CALIBRATION STANDARD
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX , INC.

Primary DI Number: 03573026551155
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 086785110 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K083536	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 40051d02-e918-43e4-9167-3c1ff9f26f9d
Public Version Date: December 20, 2022
Public Version Number: 7
DI Record Publish Date: December 19, 2016