AccessGUDID - DEVICE: NovaLisa Coxiella burnetii (Q-Fever) Phase 2 IgG (ENTICOX2G0600)

GUDID

Device Identifier (DI) Information

Brand Name: NovaLisa Coxiella burnetii (Q-Fever) Phase 2 IgG
Version or Model: COX2G060
Commercial Distribution Status: In Commercial Distribution
Catalog Number: COX2G0600
Company Name: Gold Standard Diagnostics Frankfurt GmbH

Primary DI Number: ENTICOX2G0600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 330328514 *Terms of Use

Device Description: The Coxiella burnetii (Q-Fever) Phase 2 IgG ELISA is intended for the qualitative determination of IgG class antibodies against Coxiella burnetii (Q-Fever) Phase 2 in human serum or plasma (citrate, heparin).

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:	No
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
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: 620fe44a-8f2b-43a1-86f9-03d59d771df6
Public Version Date: September 10, 2024
Public Version Number: 2
DI Record Publish Date: August 26, 2024