Duns Number:118289289
Device Description: To reduce high background that is caused by nonspecific binding of materials in human sera To reduce high background that is caused by nonspecific binding of materials in human sera to the latex beads used in flow antibody detection assays.
Catalog Number
ADSORB
Brand Name
Adsorb Out
Version/Model Number
N/A
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
PPM
Product Code Name
General Purpose Reagent
Public Device Record Key
1aed2d49-6c87-4a03-897d-204a4bd2c5db
Public Version Date
July 16, 2018
Public Version Number
1
DI Record Publish Date
June 15, 2018
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 | 17 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |
| U | Unclassified | 370 |