Duns Number:039981550
Device Description: Regan-Lowe Semi Solid Agar Deep, for Bordetella pertussis, 4ml, 13x100mm tube, optically c Regan-Lowe Semi Solid Agar Deep, for Bordetella pertussis, 4ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20(Charcoal Blood Agar with 10% Horse Blood and Cephalexin) For the selective isolation of Bordetella pertussis.
Catalog Number
Q32
Brand Name
N/A
Version/Model Number
Q32
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)
Yes
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
JSJ
Product Code Name
Culture Media, Selective And Non-Differential
Public Device Record Key
06075836-54c9-4fa8-9889-24d4e5eef378
Public Version Date
June 12, 2020
Public Version Number
1
DI Record Publish Date
June 04, 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 |