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 Telavancin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Telavancin for susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecalis (vancomycin-susceptible isolates only).
Catalog Number
$92053-1
Brand Name
Liofilchem MIC Test Strip (MTS)
Version/Model Number
Telavancin 0.016-256 µg/mL 1 strip
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
K163517,K163517,K163517
Product Code
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
Public Device Record Key
ec5a0931-34a4-4c1a-90c8-8698f25e39ee
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
April 12, 2017
Package DI Number
28055182870220
Quantity per Package
30
Contains DI Package
08055182870226
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 |