AccessGUDID - DEVICE: IFA: Granulocyte Mosaic 13 (04049016040163)

GUDID

Device Identifier (DI) Information

Brand Name: IFA: Granulocyte Mosaic 13
Version or Model: FA 1201-1003-13
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: EUROIMMUN Medizinische Labordiagnostika AG

Primary DI Number: 04049016040163
Issuing Agency: GS1
Commercial Distribution End Date: May 27, 2022
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?
55061	Multiple anti-neutrophil cytoplasmic antibody (ANCA) IVD, kit, fluorescent immunoassay	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple anti-neutrophil cytoplasmic antibodies (ANCA) in a clinical specimen, using a fluorescent immunoassay method.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MOB	Test System, Antineutrophil Cytoplasmic Antibodies (Anca)

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K051489	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: 91e7f974-c639-4959-9bc0-643b91e1d4e2
Public Version Date: November 22, 2022
Public Version Number: 4
DI Record Publish Date: September 24, 2016