Duns Number:516536641
Device Description: For control of the indirect and direct antiglobulin test. ALBAcyte® C3 Coated Red Blood C For control of the indirect and direct antiglobulin test. ALBAcyte® C3 Coated Red Blood Cells is used as a control to confirm the presence or absence of Anti-C3 reactivity of Anti-Human Globulin Reagent and as indicator cells in AHG testing.
Catalog Number
-
Brand Name
ALBAcyte C3 Coated Red Blood Cells
Version/Model Number
Z482U
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
KSF
Product Code Name
Kit, Quality Control For Blood Banking Reagents
Public Device Record Key
11afd71c-3bf0-4510-94df-45169c2cc00f
Public Version Date
March 31, 2022
Public Version Number
4
DI Record Publish Date
August 21, 2015
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 |