Duns Number:039981550
Device Description: THAYER MARTIN, MODIFIEDFor the selective isolation of N. gonorrheoeae with suppression of THAYER MARTIN, MODIFIEDFor the selective isolation of N. gonorrheoeae with suppression of most other gram-negative diplococci, gram-negative bacilli, gram-positive organisms, and yeast. Plate has a "pill pocket" receptacle for the addition of a CO2 tablet. Includes 10 CO2 tablets and 10 ziplock bags.
Catalog Number
E450
Brand Name
NA
Version/Model Number
E450
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 02, 2016
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
96df594c-211e-4ece-8e3f-23a9ec232d6e
Public Version Date
March 31, 2020
Public Version Number
3
DI Record Publish Date
September 02, 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 |