AccessGUDID - DEVICE: Etest® TIGECYCLINE (03573026549251)

GUDID

Device Identifier (DI) Information

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

Primary DI Number: 03573026549251
Issuing Agency: GS1
Commercial Distribution End Date: November 18, 2016
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?
44271	Tigecycline minimum inhibitory concentration (MIC) IVD	A graduated test strip or collection of reagents containing a specified concentration gradient of the antimicrobial tigecycline, 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 [?]
K052366	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: 259d5fa4-f76c-4872-b768-da53df8dd14e
Public Version Date: July 06, 2018
Public Version Number: 5
DI Record Publish Date: November 18, 2016