Duns Number:894671143
Device Description: EasyLyse Erythrocyte-Lysing Reagent
Catalog Number
-
Brand Name
EasyLyse Erythrocyte-Lysing Reagent
Version/Model Number
S2364
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
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GGK
Product Code Name
PRODUCTS, RED-CELL LYSING PRODUCTS
Public Device Record Key
8756698b-2a83-4f33-9ed6-2a807907baaa
Public Version Date
December 07, 2020
Public Version Number
2
DI Record Publish Date
September 17, 2020
Package DI Number
05700572013693
Quantity per Package
6
Contains DI Package
05700571112748
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Box
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 490 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 43 |
| 3 | A medical device with high risk that requires premarket approval | 5 |