Duns Number:435342134
Catalog Number
$92108-1
Brand Name
Liofilchem MTS (MIC Test Strip)
Version/Model Number
Piperacillin*- tazobactam TZP 0.016-256*
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K211672,K211672,K211672
Product Code
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
Public Device Record Key
f3d0622b-600f-4a18-98a3-be4646658dee
Public Version Date
November 04, 2021
Public Version Number
1
DI Record Publish Date
October 27, 2021
Package DI Number
18055182872951
Quantity per Package
10
Contains DI Package
08055182872954
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
box
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 25 |