Duns Number:003255213
Device Description: PEG is an additive solution intended for use as a potentiator in antibody detection, ident PEG is an additive solution intended for use as a potentiator in antibody detection, identification and compatibility testing. This product is prepared from Polyethylene glycol (PEG) in a low ionic strength solution.
Catalog Number
-
Brand Name
PEG
Version/Model Number
510179
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
-
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
KSG
Product Code Name
Media, Potentiating For In Vitro Diagnostic Use
Public Device Record Key
eff243f5-85a0-4c0f-bb3c-6990be8d4932
Public Version Date
October 18, 2018
Public Version Number
1
DI Record Publish Date
September 17, 2018
Package DI Number
10858400005104
Quantity per Package
5
Contains DI Package
00858400005107
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 | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |