Duns Number:940425333
Device Description: The GenBio Salmonella typhi ImmunoDOT test is an enzyme immunoassay for the detection of a 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.
Catalog Number
4040
Brand Name
ImmunoDOT Salmonella typhi
Version/Model Number
800-4040
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
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)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GOO
Product Code Name
Antisera, Fluorescent, All Globulins, Salmonella Spp.
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
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 32 |