Duns Number:435342134
Device Description: MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) MTS is a quantitative assay for determining the Minimum Inhibitory Concentration (M.I.C.) of antimicrobial agents against microorganisms. Liofilchem MIC Test Strip Penicillin G 0.002-32 µg/mL are specialized strips impregnated with a predefined concentration gradient of Penicillin G for susceptibility testing of Streptococcus ssp.
Catalog Number
$92103-10
Brand Name
Liofilchem MTS (MIC Test Strip)
Version/Model Number
PENICILLIN G P 0.002-32 µg/mL 10 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)
Yes
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
K181889,K181889,K181889
Product Code
JWY
Product Code Name
Manual Antimicrobial Susceptibility Test Systems
Public Device Record Key
295823a8-4354-461c-a95b-7b0ef577a73f
Public Version Date
November 26, 2018
Public Version Number
1
DI Record Publish Date
October 26, 2018
Package DI Number
18055182872876
Quantity per Package
10
Contains DI Package
08055182872879
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 |