Duns Number:276816717
Device Description: This product consists of two culture media, dispensed into one Petri dish containing separ This product consists of two culture media, dispensed into one Petri dish containing separate compartments. It is intended for use with urine specimens
Catalog Number
-
Brand Name
CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA)
Version/Model Number
CHROMID® CPS® Elite agar/Columbia CNA agar + 5% sheep blood (CPSE/CNA)
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
JXA
Product Code Name
KIT, SCREENING, URINE
Public Device Record Key
f2aec207-bdab-4aa2-9de4-48d76e00dcaf
Public Version Date
May 27, 2020
Public Version Number
1
DI Record Publish Date
May 19, 2020
Package DI Number
03573026468545
Quantity per Package
2
Contains DI Package
03573026600426
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 |