AccessGUDID - DEVICE: Fungal Serology (10634853000183)

GUDID

Device Identifier (DI) Information

Brand Name: Fungal Serology
Version or Model: 200165
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 200165
Company Name: MICROBIOLOGICS INC.

Primary DI Number: 10634853000183
Issuing Agency: GS1
Commercial Distribution End Date: November 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 060467826 *Terms of Use

Device Description: Immunodiffusion Agar, 12mL Deeps

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):	No
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?
64947	Agar medium preparation kit IVD	A collection of devices intended to be used for the preparation of an agar medium for subsequent culture of a clinical specimen or other diagnostic testing (e.g., minimum susceptibility testing). It typically includes agarose, a specific culture media formulation and transfer devices (e.g., vial adaptor, syringe). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JZP	PLATES, OUCHTERLONY AGAR

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
Storage Environment Temperature: between 4 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3aecb64e-30d1-4c75-b3fa-c8630783c29d
Public Version Date: February 09, 2024
Public Version Number: 2
DI Record Publish Date: September 26, 2022