AccessGUDID - DEVICE: Ragweed, False Franseria acanthicarpa (00816879021844)

GUDID

Device Identifier (DI) Information

Brand Name: Ragweed, False Franseria acanthicarpa
Version or Model: W004
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 74472
Company Name: HYCOR BIOMEDICAL LLC

Primary DI Number: 00816879021844
Issuing Agency: GS1
Commercial Distribution End Date: September 30, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 010558476 *Terms of Use

Device Description: 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 an allergen specific immunoglobulin E (IgE) antibody in a clinical specimen.

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:	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?
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
DGC	Ige, Antigen, Antiserum, Control

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: 317b3fa0-343b-47a5-b1e7-3ddcbbc5f4d9
Public Version Date: September 09, 2024
Public Version Number: 6
DI Record Publish Date: September 26, 2016