Duns Number:435342134
Device Description: MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentrati MIC Tests Strip is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Azithromycin 0.016-256 µg/mL are specialized strips impregnated with a predefined concentration gradient of Azithromycin for susceptibility testing of Staphylococcus aureus (methicillin-susceptible strains)
Catalog Number
$92030-10
Brand Name
Liofilchem MIC Test Strip
Version/Model Number
Azithromycin 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
K180339,K180339,K180339
Product Code
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
Public Device Record Key
caea40f7-7200-4b4c-8d0d-ef1080fe8e9d
Public Version Date
July 09, 2018
Public Version Number
1
DI Record Publish Date
June 08, 2018
Package DI Number
18055182871251
Quantity per Package
10
Contains DI Package
08055182871254
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 |