Duns Number:039981550
Device Description: CHOCOLATE with BAC / MTM BIPLT(Section I: Chocolate with Bacitracin; Section II: Modified CHOCOLATE with BAC / MTM BIPLT(Section I: Chocolate with Bacitracin; Section II: Modified Thayer Martin). For the selective isolation of fastidious bacteria.
Catalog Number
J101
Brand Name
NA
Version/Model Number
J101
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
June 17, 2020
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
10e4525e-851f-406c-b101-bc415a153e5c
Public Version Date
June 18, 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 |