Duns Number:039981550
Device Description: TRANSGROW(Modified Martin Lewis Agar with Lincomycin with CO2) For isolation of Neisseria TRANSGROW(Modified Martin Lewis Agar with Lincomycin with CO2) For isolation of Neisseria gonorrhoeae. Hold bottle upright when cap is off. Do not refrigerate after inoculation.
Catalog Number
X52
Brand Name
NA
Version/Model Number
X52
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
-
Product Code
JTY
Product Code Name
Culture Media, For Isolation Of Pathogenic Neisseria
Public Device Record Key
15c07f46-9aef-4438-bc41-958fb2502cfc
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
September 01, 2016
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 |