AccessGUDID - DEVICE: OPTIGEN® Negative Control Reagent (00813382010099)

GUDID

Device Identifier (DI) Information

Brand Name: OPTIGEN® Negative Control Reagent
Version or Model: 82062
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 82062
Company Name: Minaris Medical America, Inc.

Primary DI Number: 00813382010099
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 3
Labeler D-U-N-S® Number*: 102113867 *Terms of Use

Device Description: OPTIGEN Negative Control

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?
58947	Allergen-specific/total immunoglobulin E (IgE) 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 E (IgE) antibodies to one or multiple allergens and total immunoglobulin E (IgE total) antibodies in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DGC	IGE, ANTIGEN, ANTISERUM, CONTROL

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051677	000

Device Exempt from Premarket Submission: No 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: f00fe926-c0e8-4b3a-a211-d7e7ff11592f
Public Version Date: June 10, 2022
Public Version Number: 5
DI Record Publish Date: August 19, 2016