AccessGUDID - DEVICE: CHORUS Q FEVER PHASE II IgG (08033891322083)

GUDID

Device Identifier (DI) Information

Brand Name: CHORUS Q FEVER PHASE II IgG
Version or Model: 81171
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 81171
Company Name: DIESSE DIAGNOSTICA SENESE SPA

Primary DI Number: 08033891322083
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 435036669 *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?
51350	Coxiella burnetii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of immunoglobulin G (IgG) antibodies to Coxiella burnetii in a clinical specimen using an enzyme immunoassay (EIA) method. The assay is designed to detect infection with Coxiella burnetii, the rickettsial bacteria associated with Q fever.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GPS	Antigen, Cf, Q Fever

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 078dc65e-aac7-45e2-a3c8-69133e2f99d8
Public Version Date: January 30, 2024
Public Version Number: 1
DI Record Publish Date: January 22, 2024