AccessGUDID - DEVICE: Anti-PLA2R IFA (04049016095804)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-PLA2R IFA
Version or Model: FA 1254-2005-50
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EUROIMMUN Medizinische Labordiagnostika AG

Primary DI Number: 04049016095804
Issuing Agency: GS1
Commercial Distribution End Date: March 24, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 322209263 *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):	No
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?
62337	Phospholipase A2 receptor (PLA2R) antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative detection of antibodies to the phospholipase A2 receptor (PLA2R) in a clinical specimen, using a fluorescent immunoassay method. It is used as an aid in the diagnosis of the kidney disease known as primary membranous glomerulonephritis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PGV	Anti-Phospholipase A2 Receptor

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
DEN140002	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: 22d4751f-d916-44d7-a987-c50e7969c46d
Public Version Date: July 16, 2020
Public Version Number: 4
DI Record Publish Date: October 10, 2016