Duns Number:276816717
Device Description: Etest is a quantitative technique for determining the MIC of antimicrobial agents against Etest is a quantitative technique for determining the MIC of antimicrobial agents against microorganisms and for detection of resistance mechanisms.
Catalog Number
-
Brand Name
Etest® ESBL CT/CTL 16/1
Version/Model Number
Etest® ESBL CT/CTL 16/1
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
K001547,K001547,K001547,K001547,K001547
Product Code
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
Public Device Record Key
0d2d41fa-a272-4712-9c9b-21baac4dadf2
Public Version Date
November 01, 2019
Public Version Number
5
DI Record Publish Date
November 18, 2016
Package DI Number
03573026256753
Quantity per Package
10
Contains DI Package
03573026548094
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 |