AccessGUDID - DEVICE: Hytec Specific/Total IgE EIA (00816879022100)

GUDID

Device Identifier (DI) Information

Brand Name: Hytec Specific/Total IgE EIA
Version or Model: 74154
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 74154
Company Name: HYCOR BIOMEDICAL LLC

Primary DI Number: 00816879022100
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: 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):	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?
58946	Allergen-specific/total immunoglobulin E (IgE) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the quantitative detection of immunoglobulin E (IgE) antibodies to one or multiple allergens and total immunoglobulin E (IgE total) antibodies in a clinical specimen, using an enzyme immunoassay (EIA) method.	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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 7af3d500-79c5-483e-a8f9-fe0cc0bb755d
Public Version Date: September 06, 2024
Public Version Number: 4
DI Record Publish Date: August 15, 2018