Duns Number:039981550
Device Description: BluEcoli™ Urine Biplate, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics BluEcoli™ Urine Bi BluEcoli™ Urine Biplate, 15x100mm Biplate, 10ml/10ml. Hardy Diagnostics BluEcoli™ Urine Biplate is a urine culture media, consisting of Blood Agar on one side and BluEcoli™ Agar on the other side, which is used for the isolation of urinary pathogens and for the identification of E. coli.
Catalog Number
J123
Brand Name
N/A
Version/Model Number
J123
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
JSI
Product Code Name
Culture Media, Selective And Differential
Public Device Record Key
125b2d7f-d67e-40ad-8d9e-ee9212be32ca
Public Version Date
May 28, 2020
Public Version Number
1
DI Record Publish Date
May 20, 2020
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 |