AccessGUDID - DEVICE: ImmunoDOT Salmonella typhi (00613745000053)

GUDID

Device Identifier (DI) Information

Brand Name: ImmunoDOT Salmonella typhi
Version or Model: 800-4040
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4040
Company Name: Genbio

Primary DI Number: 00613745000053
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 940425333 *Terms of Use

Device Description: The GenBio Salmonella typhi ImmunoDOT test is an enzyme immunoassay for the detection of antibodies to Salmonella (typhoid fever) for the serological confirmation of infections in serum, plasma or heparinized whole blood. This test is intended to be performed by trained laboratory personnel only.

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?
51588	Salmonella typhi total antibody IVD, kit, immunoblot	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of total antibodies to Salmonella typhi in a clinical specimen using an immunoblot method. The assay is designed to detect infection with Salmonella typhi, the bacteria associated with typhoid fever.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GOO	Antisera, Fluorescent, All Globulins, Salmonella Spp.

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
Device Size Text, specify: 25 tests

Device Record Status

Public Device Record Key: 32921a9e-a9c7-44d9-8f73-4829ff7d9096
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 24, 2016