Duns Number:427395277
Device Description: The Abacus 3 Cap Piercer (Abacus 3CP) is a fully automated, bench top hematology cell coun The Abacus 3 Cap Piercer (Abacus 3CP) is a fully automated, bench top hematology cell counter, is a device used to identify one or more of the formed elements of the blood. The Diatron Abacus 3 CP System is a quantitative multi-parameter automated hematology analyzer designed for in-vitro-diagnostic use in clinical laboratories for enumeration of the following parameters: WBC, LYM%, LYM#, MID%, MID#, GRA%,GRA#, RBC, HGB, HCT, MCV, MCH, MCHC, RDW, PLT, MPV in EDTA anti-coagulated venous whole blood samples.
Catalog Number
A3CPC-1
Brand Name
ABACUS 3CP Hematology Analyzer
Version/Model Number
ABACUS 3CP
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"
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For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
GKZ
Product Code Name
Counter, Differential Cell
Public Device Record Key
afc58ab8-25fa-426c-b774-851a7e7ab035
Public Version Date
September 16, 2022
Public Version Number
5
DI Record Publish Date
October 06, 2016
Package DI Number
15999883586713
Quantity per Package
1
Contains DI Package
05999883586716
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 | 8 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 3 |