Duns Number:516536641
Device Description: ALBAhance LISS Additive Reagent.
Catalog Number
-
Brand Name
ALBAhance LISS Additive Reagent
Version/Model Number
Z333U
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
40b4435b-df5e-42a4-808c-68b2f48c80ef
Public Version Date
March 31, 2022
Public Version Number
6
DI Record Publish Date
November 14, 2014
Package DI Number
05060242471117
Quantity per Package
10
Contains DI Package
05060242471544
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
Carton
Device Class | Device Class Description | No of Devices |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 8 |