AccessGUDID - DEVICE: Etest® CHLORAMPHENICOL (03573026548827)

GUDID

Device Identifier (DI) Information

Brand Name: Etest® CHLORAMPHENICOL
Version or Model: Etest® CHLORAMPHENICOL
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: BIOMERIEUX SA

Primary DI Number: 03573026548827
Issuing Agency: GS1
Commercial Distribution End Date: May 14, 2018
Device Count: 1
Labeler D-U-N-S® Number*: 276816717 *Terms of Use

Device Description: Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.

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:	Yes
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?
44820	Chloramphenicol minimum inhibitory concentration (MIC) IVD	A graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial chloramphenicol, intended to be used to determine the minimum inhibitory concentration (MIC) for a particular microorganism, isolated from a clinical specimen by culture.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JWY	Manual Antimicrobial Susceptibility Test Systems

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K980342	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 -20 and 22 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 0e9d9239-719e-493f-bd5d-5a6fa02b6f79
Public Version Date: July 06, 2018
Public Version Number: 4
DI Record Publish Date: November 18, 2016