Duns Number:039981550
Device Description: CLED (Cystine Lactose Electrolyte Deficient): For the isolation, enumeration, and presumpt CLED (Cystine Lactose Electrolyte Deficient): For the isolation, enumeration, and presumptive identification of urinary pathogens.Mueller Hinton: For antimicrobial susceptibility testing of non-fastidious bacteria.
Catalog Number
J212
Brand Name
NA
Version/Model Number
J212
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
October 25, 2021
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
K811646,K811646
Product Code
JTZ
Product Code Name
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Public Device Record Key
91fcb020-eb37-4cde-a505-db95d3182724
Public Version Date
October 26, 2021
Public Version Number
4
DI Record Publish Date
September 01, 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 |