Duns Number:276816717
Device Description: API 20 E is a standardized identification system for Enterobacteriaceae and other non-fast API 20 E is a standardized identification system for Enterobacteriaceae and other non-fastidious, Gramnegative rods
Catalog Number
-
Brand Name
API® 20 E
Version/Model Number
API 20 E™
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)
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
731c4370-d4ac-4aa4-b10c-1ec2769d19a1
Public Version Date
December 09, 2021
Public Version Number
2
DI Record Publish Date
April 10, 2020
Package DI Number
03573026048013
Quantity per Package
4
Contains DI Package
03573026588489
Package Discontinue Date
-
Package Status
In Commercial Distribution
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 |