Duns Number:435342134
Device Description: The MTS™ Tetracycline 0.016-256 μg/mL is a quantitative method intended for the in vitro d The MTS™ Tetracycline 0.016-256 μg/mL is a quantitative method intended for the in vitro determination of antimicrobial susceptibility of bacteria. MTS™ consists of specialized paper impregnated with a pre-defined concentration gradient of an antimicrobial agent, which is used to determine the minimum inhibitory concentration (MIC) in μg/mL of antimicrobial agents against bacteria as tested on agar media using overnight incubation and manual reading procedures. The MTS™ Tetracycline at concentrations of 0.016-256 μg/mL should be interpreted at 16-20 hours of incubation.Tetracycline has been shown to be active both clinically and in vitro against these bacterial species according to the FDA drug approved label:Staphylococcus aureusAcinetobacter baumanniiEscherichia coliKlebsiella aerogenesKlebsiella oxytocaKlebsiella pneumoniae
Catalog Number
$92114-10
Brand Name
Liofilchem Mic Test Strip (MTS)
Version/Model Number
Tetracycline TE 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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K183140,K183140,K183140
Product Code
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
Public Device Record Key
d4ebb012-0d82-4d46-8cee-57ce86b57f0d
Public Version Date
March 12, 2019
Public Version Number
1
DI Record Publish Date
March 04, 2019
Package DI Number
18055182873057
Quantity per Package
10
Contains DI Package
08055182873050
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 |