AccessGUDID - DEVICE: IMMY (00816387020100)

GUDID

Device Identifier (DI) Information

Brand Name: IMMY
Version or Model: AF0110
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Immuno-Mycologics, Inc.

Primary DI Number: 00816387020100
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 099550915 *Terms of Use

Device Description: Aspergillus terreus ID Antigen

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):	Yes
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?
51987	Multiple Aspergillus species total antibody IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is 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
JWT	Antigen, Cf, 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 231cfa9e-f1a5-4e4e-9efa-4501a606b200
Public Version Date: March 28, 2022
Public Version Number: 3
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: 14053604669
Email: customerservice@immy.com

MENU
- Home
- About
- News
- API
- Download
- Help

FDA TOOLS & RESOURCES