Duns Number:069550929
Device Description: Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enum Cystine Lactose Electrolyte Deficient (CLED) Agar is used for the differentiation and enumeration of microorganisms in urine.
Catalog Number
NCM0256
Brand Name
CLED Agar (Legacy 7122)
Version/Model Number
0
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
-
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
JSH
Product Code Name
Culture Media, Non-Selective And Differential
Public Device Record Key
d9cbc8f4-1e31-4620-a76d-cf3360c152c3
Public Version Date
April 18, 2022
Public Version Number
1
DI Record Publish Date
April 08, 2022
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 | 6 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4 |