AccessGUDID - DEVICE: Fungal Serology (10634853000435)

GUDID

Device Identifier (DI) Information

Brand Name: Fungal Serology
Version or Model: 200350
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 200350
Company Name: MICROBIOLOGICS INC.

Primary DI Number: 10634853000435
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: Aspergillus Pooled Antiserum, 2mL

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?
51986	Multiple Aspergillus species total antibody IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total antibodies to one or multiple species of the fungus Aspergillus, which may include Aspergillus niger, Aspergillus flavus, Aspergillus terreus and/or Aspergillus fumigatus in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KFG	ANTISERUM, POSITIVE CONTROL, ASPERGILLUS SPP.

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: exactly -20 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 35b24835-ec08-4c8a-95d5-cff90c0177ee
Public Version Date: February 09, 2024
Public Version Number: 2
DI Record Publish Date: September 26, 2022