Duns Number:790175165
Device Description: QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vit QuickProfile™ 2019-nCoV IgG/IgM Test Card is an immunochromatography based one step in vitro test. It is designed for the rapid qualitative determination of IgG and IgM antibodies to the 2019 novel coronavirus (2019-nCoV, SARS-CoV-2) in human serum, plasma, or whole blood. QuickProfile™ 2019-nCoV IgG/IgM Test Card is a supplemental rapid screening tool for symptomatic or asymptomatic carriers of the virus.
Catalog Number
71108B
Brand Name
QuickProfile™ 2019-nCoV IgG/IgM Antibody Test
Version/Model Number
71108B
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
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
-
Product Code
QKO
Product Code Name
Reagent, Coronavirus Serological
Public Device Record Key
dc5124d6-910c-4858-bdc7-72e9d2e11107
Public Version Date
June 10, 2022
Public Version Number
2
DI Record Publish Date
April 03, 2020
Package DI Number
M90171108B1
Quantity per Package
25
Contains DI Package
M90171108B0
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Kit
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 117 |
| U | Unclassified | 2 |