AccessGUDID - DEVICE: Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit

GUDID

Device Identifier (DI) Information

Brand Name: Human IgA Subclass NL BINDARID™ Radial Immunodiffusion Kit – Bulk Kit
Version or Model: RK015
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: THE BINDING SITE GROUP LIMITED

Primary DI Number: 05051700010375
Issuing Agency: GS1
Commercial Distribution End Date: May 31, 2023
Device Count: 1
Labeler D-U-N-S® Number*: 347045614 *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:	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?
61985	Immunoglobulin A subclass (IgA subclass) IVD, kit, precipitation/immunodiffusion	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple immunoglobulin A subclasses (IgA subclasses) in a clinical specimen, using a precipitation/immunodiffusion method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CZP	Iga, 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
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: 37279c1f-5e81-472c-848c-ec0adcdc187a
Public Version Date: July 21, 2023
Public Version Number: 4
DI Record Publish Date: September 24, 2016