AccessGUDID - DEVICE: MYCOFAST US (03661540100031)

GUDID

Device Identifier (DI) Information

Brand Name: MYCOFAST US
Version or Model: 00050
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00050
Company Name: ELITECH MICROBIO

Primary DI Number: 03661540100031
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 299579792 *Terms of Use

Device Description: MYCOFAST US has been designed for the detection, enumeration and identification of Ureaplasma urealyticum (U.u.) and Mycoplasma hominis (M.h.) in various clinical sspecimens.

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:	Yes
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?
58645	Mycoplasma species broth culture medium IVD	A supplemented broth culture medium intended to be used to enhance the growth of Mycoplasma species in a clinical specimen.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
JTO	Discs, Strips And Reagents, Microorganism Differentiation

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a838bea4-92b1-43d3-bcb6-c175a071be12
Public Version Date: January 10, 2019
Public Version Number: 1
DI Record Publish Date: December 10, 2018