Duns Number:276816717
Device Description: API 20 NE is a standardized system for the ID of non-fastidious, non-enteric Gram-negative API 20 NE is a standardized system for the ID of non-fastidious, non-enteric Gram-negative rods (e.g. Pseudomonas, Acinetobacter, Flavobacterium, Moraxella, etc.)
Catalog Number
-
Brand Name
API® 20 NE
Version/Model Number
20050
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
-
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
2b0f9657-865a-4a92-87b2-af017b67c1dd
Public Version Date
April 20, 2020
Public Version Number
1
DI Record Publish Date
April 10, 2020
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 |