Duns Number:435342134
Device Description: MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentratio MIC Test Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Dalbavancin 0.002-32 μg/ml are specialized strips impregnated with a predefined concentration gradient of dalbavancin for susceptibility testing of Staphylococcus aureus and Enterococcus faecalis
Catalog Number
$92137-10
Brand Name
Liofilchem MIC Test Strip (MTS)
Version/Model Number
Dalbavancin 0.002-32 µg/ml 10 strips
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
K153569,K153569,K153569
Product Code
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
Public Device Record Key
66e7962d-2ac6-4778-b84f-f3c28a5ccdf5
Public Version Date
January 23, 2019
Public Version Number
4
DI Record Publish Date
January 31, 2017
Package DI Number
18055182870025
Quantity per Package
10
Contains DI Package
08055182870028
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 |