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 Linezolid 0.016 – 256 μg/mL are specialized strips impregnated with a predefined concentration gradient of Linezolid for susceptibility testing of Staphylococcus aureus (including methicillin-resistant isolates), Enterococcus faecium (vancomycin resistant isolates only).
Catalog Number
$92135-10
Brand Name
Liofilchem MIC Test Strip (MTS)
Version/Model Number
Linezolid 0.016 – 256 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
K180330,K180330,K180330
Product Code
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
Public Device Record Key
8f477652-c41c-45c3-acb3-0675b780b68c
Public Version Date
July 06, 2018
Public Version Number
2
DI Record Publish Date
May 09, 2018
Package DI Number
18055182873323
Quantity per Package
10
Contains DI Package
08055182873326
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 |