Duns Number:039981550
Device Description: CarboFerm™ I, rapid carbohydrate test for Neisseria and Moraxella, 24 tests per kitFor the CarboFerm™ I, rapid carbohydrate test for Neisseria and Moraxella, 24 tests per kitFor the rapid identification and differentiation of Neisseria spp., including N. gonorrhoeae and N. meningitidis, and Moraxella (Branhamella) catarrhalis. CarboFerm™ uses acid production from carbohydrates to differentiate and identify Neisseria species and M. catarrhalis. Performs a glucose, lactose, maltose, sucrose, and butyrate test
Catalog Number
Z98
Brand Name
CarboFerm™
Version/Model Number
Z98
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
LIB
Product Code Name
Device, General Purpose, Microbiology, Diagnostic
Public Device Record Key
169a2d37-970e-44c4-906f-24f2e5e48825
Public Version Date
August 20, 2020
Public Version Number
1
DI Record Publish Date
August 12, 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 |