Duns Number:039981550
Device Description: HTM AGAR(Haemophilus Test Medium) For disk diffusion sensitivity testing of Haemophilus sp HTM AGAR(Haemophilus Test Medium) For disk diffusion sensitivity testing of Haemophilus spp.
Catalog Number
G33
Brand Name
NA
Version/Model Number
G33
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
JSO
Product Code Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Public Device Record Key
9007a4e2-6ba9-4143-80d0-a3d2b032ce54
Public Version Date
March 29, 2018
Public Version Number
2
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 |