Duns Number:188354831
Device Description: 1. QUANTA Flash β2GP1 IgG Reagent Cartridge1. QUANTA Flash β2GP1 IgG Calibrator 1 1. QUANT 1. QUANTA Flash β2GP1 IgG Reagent Cartridge1. QUANTA Flash β2GP1 IgG Calibrator 1 1. QUANTA Flash β2GP1 IgG Calibrator 2
Catalog Number
-
Brand Name
QUANTA Flash® β2GPI IgG Reagents
Version/Model Number
701248
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
K091556
Product Code
MSV
Product Code Name
System,Test,Antibodies,B2 - Glycoprotein I (B2 - Gpi)
Public Device Record Key
5a6fcb9e-e71f-40d5-b362-cdaa54cf4b8d
Public Version Date
October 10, 2022
Public Version Number
4
DI Record Publish Date
August 31, 2016
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 215 |