Duns Number:381527001
Device Description: Papain is a ready to use stabilized solution of proteolytic enzyme, derived from papaya (C Papain is a ready to use stabilized solution of proteolytic enzyme, derived from papaya (Carica papaya), used to treat human red blood cells in immunohematology.Intended to be used with DIAGAST Anti-Lea (LE1) (REF 210541)
Catalog Number
210545
Brand Name
Papain
Version/Model Number
210545
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)
Yes
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
KSK
Product Code Name
Solution, Stabilized Enzyme
Public Device Record Key
523d5e93-b8c3-4f1e-b998-9bb536908b32
Public Version Date
October 21, 2020
Public Version Number
2
DI Record Publish Date
May 01, 2018
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 |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 2 |