Duns Number:039981550
Device Description: Phosphate Buffer, pH 6.8, 1 liter, polycarbonate bottle, order by the package of 10Phospha Phosphate Buffer, pH 6.8, 1 liter, polycarbonate bottle, order by the package of 10Phosphate Buffer, 500ml for the preparation of specimens for AFB culture
Catalog Number
U192
Brand Name
N/A
Version/Model Number
U192
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
-
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
ac62b3ab-a9ff-4e36-9130-4c375dbf4f1a
Public Version Date
June 15, 2020
Public Version Number
1
DI Record Publish Date
June 05, 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 |