AccessGUDID - DEVICE: Anti-Glutamate receptor (type NMDA) IFA (04049016092575)

GUDID

Device Identifier (DI) Information

Brand Name: Anti-Glutamate receptor (type NMDA) IFA
Version or Model: FA 112d-2010-51
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EUROIMMUN Medizinische Labordiagnostika AG

Primary DI Number: 04049016092575
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?
62318	N-methyl-D-aspartate (NMDA) receptor antibody IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to N-methyl-D-aspartate (NMDA) receptor (a glutamate receptor) in a clinical specimen, using a fluorescent immunoassay method. It is used to aid in the diagnosis of the autoimmune condition NMDA encephalitis, which causes neurologic and psychiatric symptoms.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OSK	Anti-Glutamate Receptor (Type Nmda) Ifa

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K100017	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: 6baaedd3-a698-4ce8-ac67-eef5d676fca9
Public Version Date: July 16, 2020
Public Version Number: 4
DI Record Publish Date: October 10, 2016