AccessGUDID - DEVICE: Spotted Fever Rickettsia IgG ELISA Kit (B266SFG96K0)

GUDID

Device Identifier (DI) Information

Brand Name: Spotted Fever Rickettsia IgG ELISA Kit
Version or Model: N/A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SFG96K
Company Name: FULLER LABORATORIES

Primary DI Number: B266SFG96K0
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 859340390 *Terms of Use

Device Description: An EIA assay for spotted fever Rickettsiosis IgG levels

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?
51285	Multiple Rickettsia species (spotted fever group) 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 one or multiple species of the rickettsial bacteria associated with spotted fever in a clinical specimen, using an enzyme immunoassay (EIA) method. Rickettsia species intended to be detected may include Rickettsia rickettsii, R. akari, R. conorii, R. sibirica, R. australis, R. japonica, R. africae, R. honei and/or R. felis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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: 7431c521-2bbd-4232-a856-817e9f551dd7
Public Version Date: November 08, 2019
Public Version Number: 1
DI Record Publish Date: October 31, 2019