AccessGUDID - DEVICE: Access Total IgE (15099590221324)

GUDID

Device Identifier (DI) Information

Brand Name: Access Total IgE
Version or Model: 35000
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 35000
Company Name: Beckman Coulter, Inc.

Primary DI Number: 15099590221324
Issuing Agency: GS1
Commercial Distribution End Date: December 30, 2016
Device Count: 1
Labeler D-U-N-S® Number*: 008254708 *Terms of Use

Device Description: The Access Total IgE assay is a paramagnetic particle, chemiluminescent immunoassay for the qualitative determination of total E (IgE) levels in human serum and plasma (heparin, EDTA) using the Access Immunoassay Systems.

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:	No
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?
53775	Total immunoglobulin E (IgE total) IVD, kit, chemiluminescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total immunoglobulin E (IgE total) in a clinical specimen, using a chemiluminescent immunoassay method.	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: bcf6cdce-4c45-4ddf-b074-2cad25e09bf6
Public Version Date: December 24, 2018
Public Version Number: 3
DI Record Publish Date: September 09, 2016