AccessGUDID - DEVICE: OPTIGEN® Allergen-Specific IgE Assay

GUDID

Device Identifier (DI) Information

Brand Name: OPTIGEN® Allergen-Specific IgE Assay - US Food 25 (100 ND)
Version or Model: 85066
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 85066
Company Name: Minaris Medical America, Inc.

Primary DI Number: 00813382010440
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 102113867 *Terms of Use

Device Description: KIT, OPTIGEN US Food 25

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:	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?
61955	Allergen-specific immunoglobulin E (IgE) antibody IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergen(s) in a clinical specimen, using a chemiluminescent immunoassay method. It is typically used to screen for allergies associated with certain conditions (e.g., food intolerance).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PUW	System, test, radioallergosorbent (Rast) immunological, exempt allergens

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 2 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 96fb9cf4-37b5-43d3-8b3c-64e5f057e23c
Public Version Date: August 03, 2023
Public Version Number: 4
DI Record Publish Date: May 22, 2019