Duns Number:516536641
Device Description: For in vitro diagnostic use only.For use as an enzyme solution with ORTHO™ Sera Anti-Lea, For in vitro diagnostic use only.For use as an enzyme solution with ORTHO™ Sera Anti-Lea, Anti-Leb, Anti-Jka and Anti-Jkb Blood Grouping Reagents.The ORTHO™ Sera Papain is used to enhance reactivity of ORTHO™ Sera red blood cell antigen typing reagents and redblood cells when used in in vitro immunohematology assays.
Catalog Number
-
Brand Name
ORTHOTM Sera Papain
Version/Model Number
6904840
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 01, 2017
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
KSK
Product Code Name
Solution, Stabilized Enzyme
Public Device Record Key
3a904d82-384f-4e83-a273-e111726c552d
Public Version Date
March 31, 2022
Public Version Number
4
DI Record Publish Date
August 30, 2017
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. | 8 |