Duns Number:276816717
Device Description: API 50 CHB/E Medium is for ID of Bacillus, related genera, and GN rods (Enterobacteriaceae API 50 CHB/E Medium is for ID of Bacillus, related genera, and GN rods (Enterobacteriaceae and Vibrionaceae). It allows fermentation of 49 carbohydrates on API 50 CH strip
Catalog Number
-
Brand Name
API®50 CHB/E
Version/Model Number
API®50 CHB/E
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
JSC
Product Code Name
CULTURE MEDIA, GENERAL NUTRIENT BROTH
Public Device Record Key
7f3443cb-0353-4fc1-a4d0-a6065cc19c73
Public Version Date
April 20, 2020
Public Version Number
1
DI Record Publish Date
April 10, 2020
Package DI Number
03573026087494
Quantity per Package
10
Contains DI Package
03573026588724
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 82 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 156 |
| 3 | A medical device with high risk that requires premarket approval | 3 |