Duns Number:883350811
Device Description: Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA)
Catalog Number
Q01-310H
Brand Name
ReQuest
Version/Model Number
ANA Screen
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
LKJ
Product Code Name
Antinuclear Antibody, Antigen, Control
Public Device Record Key
19e45c8c-4e1d-48a8-b450-5b43bdeba137
Public Version Date
March 29, 2018
Public Version Number
2
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 | 20 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 44 |