AccessGUDID - DEVICE: UP20 Negative Control Reagent (00813382010358)

GUDID

Device Identifier (DI) Information

Brand Name: UP20 Negative Control Reagent
Version or Model: 80108
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 80108
Company Name: Minaris Medical America, Inc.

Primary DI Number: 00813382010358
Issuing Agency: GS1
Commercial Distribution End Date: March 09, 2021
Device Count: 3
Labeler D-U-N-S® Number*: 102113867 *Terms of Use

Device Description: UP20 Negative Control Reagent

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: f54b6cf9-ee79-434a-a7d0-2d718a10e950
Public Version Date: June 10, 2022
Public Version Number: 6
DI Record Publish Date: June 15, 2017