AccessGUDID - DEVICE: IgE Conjugate MCS (00081687902221)

GUDID

Device Identifier (DI) Information

Brand Name: IgE Conjugate MCS
Version or Model: 308174
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: HYCOR BIOMEDICAL LLC

Primary DI Number: 00081687902221
Issuing Agency: GS1
Commercial Distribution End Date: July 27, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 010558476 *Terms of Use

Device Description: No description.

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?
53782	Allergen-specific immunoglobulin E (IgE) 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 immunoglobulin E (IgE) antibodies to one or multiple allergens in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DHB	System, Test, Radioallergosorbent (Rast) Immunological

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7b287cf6-8088-49e9-9ff5-0d17ba83d96c
Public Version Date: June 10, 2022
Public Version Number: 4
DI Record Publish Date: September 26, 2016