Duns Number:039981550
Device Description: DTM (Dermatophyte Test Media) Agar Slant, 7.5ml Slant, order by the package of 20(Dermatop DTM (Dermatophyte Test Media) Agar Slant, 7.5ml Slant, order by the package of 20(Dermatophyte Test Medium) For the isolation and identification of dermatophytic fungi such as Microsporum canis, the causative agent of ringworm. It is also designed to detect dermatophytes such as Epidermophyton and Trichophyton spp. The addition of Gentamicin and Chlortetracycline act as broad spectrum antimicrobics to inhibit a wide range of interfering gram-positive and gram-negative bacteria. Cycloheximide is added to inhibit saprophytic non-pathogenic fungi. Phenol red, the pH indicator, is affected by the presence of dermatophytes (Epidermophyton, Microsporum, and Trichophyton spp.), which all produce alkaline metabolites. Vials are made of shatter resistant polycarbonate plastic with a wide mouth opening for easy inoculatio
Catalog Number
L27
Brand Name
N/A
Version/Model Number
L27
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
-
Product Code
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
12e0c8e4-c536-45fb-ae39-6fe2bc37d35d
Public Version Date
June 11, 2020
Public Version Number
1
DI Record Publish Date
June 03, 2020
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 630 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 132 |