Duns Number:039981550
Device Description: THAYER MARTIN, MODIFIEDHardy Diagnostics Modified Thayer Martin (MTM) is a selective mediu THAYER MARTIN, MODIFIEDHardy Diagnostics Modified Thayer Martin (MTM) is a selective medium used in qualitative procedures for the isolation of Neisseria gonorrhoeae with suppression of most other gram-negative diplococci, gram-negative bacilli, gram-positive organisms, and yeast.
Catalog Number
E130BX
Brand Name
NA
Version/Model Number
E130BX
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
K934331,K934331
Product Code
JTY
Product Code Name
Culture Media, For Isolation Of Pathogenic Neisseria
Public Device Record Key
aa13ac02-4afd-4d55-bb2b-a17ae015ef5a
Public Version Date
April 08, 2020
Public Version Number
1
DI Record Publish Date
March 31, 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 |