Duns Number:227530649
Device Description: Chemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV701 and 1 bottle o Chemiluminescent substrate comprised of 1 bottle of Luminol Reagent - EV701 and 1 bottle of Peroxide Reagent. The analyser uses a 1:1 mixture of the two solutions as a working signal reagent - EV701 to generate a chemiluminescent signal which can be detected by the imaging module of the Evidence™ analyser.
Catalog Number
EV3601
Brand Name
REAG SGNL - EV701
Version/Model Number
EV3601
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
K030360
Product Code
JJE
Product Code Name
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Public Device Record Key
d5eee930-1f26-4949-9ed7-acace5d24d77
Public Version Date
December 21, 2020
Public Version Number
3
DI Record Publish Date
September 26, 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 | 305 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 258 |