Duns Number:188354831
Device Description: 1. 1 QUANTA Flash ENA7 Reagent Cartridge2. 1 Resuspension buffer3. 1 Transfer pipet"
Catalog Number
-
Brand Name
QUANTA Flash® ENA7 Reagents
Version/Model Number
701258
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
K122923
Product Code
LLL
Product Code Name
Extractable Antinuclear Antibody, Antigen And Control
Public Device Record Key
af12afe0-042c-4930-8825-0d8000d7bc55
Public Version Date
March 08, 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 |