Duns Number:276816717
Device Description: Etest is a quantitative technique for determining susceptibility of clinically significant Etest is a quantitative technique for determining susceptibility of clinically significant bacteria. It provides a gradient of 15 doubling dilutions for MIC determination.
Catalog Number
-
Brand Name
Etest® PLAZOMICIN
Version/Model Number
Etest® PLAZOMICIN
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
K200512,K200512
Product Code
JWY
Product Code Name
Manual antimicrobial susceptibility test systems
Public Device Record Key
aea42caa-bd0f-4e3d-b67b-dc935d83f40d
Public Version Date
July 27, 2020
Public Version Number
1
DI Record Publish Date
July 19, 2020
Package DI Number
03573026560911
Quantity per Package
30
Contains DI Package
03573026603229
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 |