Duns Number:276816717
Device Description: Isolation, enumeration and direct or presumptive identification of urinary tract infection Isolation, enumeration and direct or presumptive identification of urinary tract infection organisms
Catalog Number
-
Brand Name
chromID® CPS® Elite Agar CPSE
Version/Model Number
chromID® CPS® Elite Agar CPSE
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
200122d1-e554-4c73-a11b-920f0c53aea0
Public Version Date
May 27, 2020
Public Version Number
1
DI Record Publish Date
May 19, 2020
Package DI Number
03573026443900
Quantity per Package
10
Contains DI Package
03573026600389
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 |