AccessGUDID - DEVICE: Fungal Serology (10634853000213)

GUDID

Device Identifier (DI) Information

Brand Name: Fungal Serology
Version or Model: 200185
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 200185
Company Name: MICROBIOLOGICS INC.

Primary DI Number: 10634853000213
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: Candida 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?
52038	Multiple Candida species immunoglobulin A (IgA)/IgG/IgM 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 immunoglobulin A (IgA), immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies to multiple species of the yeast Candida in a clinical specimen. Candida species intended to be assayed may include Candida albicans, Candida krusei, Candida glabrata, Candida parapsilosis and/or Candida tropicalis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LSG	CANDIDA SPECIES, ANTIBODY DETECTION

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: df06f598-c84a-4e10-8697-8256fb2b30eb
Public Version Date: February 09, 2024
Public Version Number: 2
DI Record Publish Date: September 26, 2022