AccessGUDID - DEVICE: MYCOPLASMA CONTROL (03661540100505)

GUDID

Device Identifier (DI) Information

Brand Name: MYCOPLASMA CONTROL
Version or Model: 00900
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 00900
Company Name: ELITECH MICROBIO

Primary DI Number: 03661540100505
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 299579792 *Terms of Use

Device Description: The MYCOPLASMA CONTROL kit contains Ureaplasma urealyticum (U.u) and Mycoplasma hominis (M.h) strains and has been designed for the quality control of liquid media methods of in vitro urogenital mycoplasma diagnosis.

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):	No
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?
61331	Multiple bacteria species culture isolate identification control IVD, kit	A collection of reagents and other associated materials intended to be used to verify the performance of one or multiple biochemical tests used for the differentiation and/or identification of multiple bacteria species that have been isolated by culture from a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JTR	Kit, Quality Control For Culture Media

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: 2338a36c-7031-4855-aaff-b284eba1e182
Public Version Date: February 11, 2019
Public Version Number: 1
DI Record Publish Date: January 09, 2019