Duns Number:276816717
Device Description: Detection in enterobacteria of indole production and the presence of a tryptophan deaminas Detection in enterobacteria of indole production and the presence of a tryptophan deaminase (TDA). It allows presumptive differentiation of bacteria possessing these characteristics
Catalog Number
-
Brand Name
ID indole TDA
Version/Model Number
ID indole TDA
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"
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For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSS
Product Code Name
KIT, IDENTIFICATION, ENTEROBACTERIACEAE
Public Device Record Key
e2d7e7bf-4aa0-4fce-bdb2-6f2a9a68bc00
Public Version Date
July 29, 2019
Public Version Number
1
DI Record Publish Date
July 19, 2019
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |