Duns Number:276816717
Device Description: API 50 CHL Medium, for ID of Lactobacillus and related genera, is a ready-to-use allowing API 50 CHL Medium, for ID of Lactobacillus and related genera, is a ready-to-use allowing fermentation of the 49 carbohydrates on the API 50 CH strip (Ref. 50 300).
Catalog Number
-
Brand Name
API®50 CHL
Version/Model Number
API®50 CHL
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
06cc5ef6-0501-42f1-9e37-0b8f891d7905
Public Version Date
April 20, 2020
Public Version Number
1
DI Record Publish Date
April 10, 2020
Package DI Number
03573026087456
Quantity per Package
10
Contains DI Package
03573026588717
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 |