Duns Number:784143778
Device Description: Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employing native Anti-Beta 2 Glycoprotein Screen ELISA is a solid phase enzyme immunoassay employing native Beta-2glycoprotein I highly purified from human plasma for the combined quantitative and qualitative detection of IgA, IgG and IgM antibodies against Beta-2-glycoprotein I in human serum.
Catalog Number
35-B2SHU-E01
Brand Name
Anti-Beta 2 Glycoprotein Screen ELISA
Version/Model Number
35-B2SHU-E01
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
August 01, 2019
Issuing Agency
In HIBCC
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
K062217
Product Code
MSV
Product Code Name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Public Device Record Key
2a35efec-4f83-490a-9851-873767e7d1d5
Public Version Date
September 20, 2022
Public Version Number
4
DI Record Publish Date
August 28, 2017
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 | 42 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |