AccessGUDID - DEVICE: Human IgA Control Pack for use on the SPAPLUS® (05051700018890)

GUDID

Device Identifier (DI) Information

Brand Name: Human IgA Control Pack for use on the SPAPLUS®
Version or Model: NQ010.S
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: THE BINDING SITE GROUP LIMITED

Primary DI Number: 05051700018890
Issuing Agency: GS1
Commercial Distribution End Date: August 01, 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?
41766	Total immunoglobulin A (IgA total) IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of total immunoglobulin A (IgA total) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)

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: 2967584e-cd56-4943-9cd5-a5309c5718b6
Public Version Date: January 10, 2024
Public Version Number: 3
DI Record Publish Date: January 26, 2018