Duns Number:039981550
Device Description: Phosphate Buffered Saline (PBS), 1.0ml, 13x100mm tube, optically clear, shatter resistant, Phosphate Buffered Saline (PBS), 1.0ml, 13x100mm tube, optically clear, shatter resistant, polycarbonate tube, order by the package of 20Hardy Diagnostics Phosphate Buffered Saline (pH of 7.5) is recommended as a diluent for quantitative culturing or as a rinsing agent in microbiological, immunological, histological and molecular testing procedures.
Catalog Number
R201
Brand Name
N/A
Version/Model Number
R201
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
LIB
Product Code Name
Device, General Purpose, Microbiology, Diagnostic
Public Device Record Key
ecfbb24b-df69-4631-bac6-481701447439
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 |