AccessGUDID - DEVICE: IgA (05055273203882)

GUDID

Device Identifier (DI) Information

Brand Name: IgA
Version or Model: IA3832
Commercial Distribution Status: In Commercial Distribution
Catalog Number: IA3832
Company Name: RANDOX LABORATORIES LIMITED

Primary DI Number: 05055273203882
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 227530649 *Terms of Use

Device Description: The product is intended for the quantitative in vitro determination of IgA in serum or plasma.

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?
54979	Immunoglobulin A antibody (anti-IgA) 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 antibodies to Immunoglobulin A (anti-IgA) in a clinical specimen.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CZP	Iga, Antigen, Antiserum, Control

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K955794	000

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: f669c649-3cbb-4bc0-82d3-3a6da6ffc631
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 24, 2016