CELL-DYN Systems Controls, Calibrators, and Reagents

CELL-DYN Hematology Controls are stable whole blood preparations used to monitor instrument performance. Controls are available in three assayed levels with results in the low, normal and high ranges to meet the laboratory’s quality control needs. Packaged in sets of 3 levels (full pack = 12 tubes, half pack = 6 tubes) or single level (normal or reticulocyte only offered for some analyzers).

CELL-DYN Controls offer eQC, a global interlaboratory online quality control program for peer group reporting and results.

CELL-DYN Calibrators are stable whole blood preparations used to set and verify the calibration of CELL-DYN systems. Calibrators ship with 2 tubes or vials contained in a package.

Controls and Calibrators are contained in plastic tubes to improve safety and performance by reducing the risk of breakage.

CELL-DYN Reagents for Immuno T-Cell (CD 3/4/8) and Immuno platelets (CD61) are also offered. Each kit contains reagent to evaluate 20 or 40 tests. These reagents ship in resealable storage pouches.

CELL-DYN 16 Control is a hematology whole blood quality control material used to monitor results obtained on CELL-DYN hematology systems.

Assay values are provided for:
CELL-DYN 1800
CELL-DYN 1700
CELL-DYN 1600*
CELL-DYN 1400*
CELL-DYN 1300*
CELL-DYN 1200

*assay values are provided for use outside of the United States.

Features:
8 Consecutive-Day Open-Tube Stability
120 Days Closed Tube Stability (approximate)
Run in Open or Closed Mode (pierceable cap)
Assay disk to automate value changes

List Number	Description	Size
99109-01	CELL-DYN 16 Tri-Level Control (FULL PACK)	12 x 2.5 mL Tubes
99105-01	CELL-DYN 16 HALF PACK Tri-Level Control	6 x 2.5 mL Tubes
02H40-01	CELL-DYN NORMAL PACK (SINGLE LEVEL)	6 x 2.5 mL Tubes
01H92-01	CELL-DYN 16 CONTROL ASSAY DISK	1 disk

CELL-DYN Calibrator is a whole blood calibrator used to calibrate CELL-DYN hematology systems. Calibration values are provided for WBC, RBC, HGB, MCV, and PLT parameters.

Assay values are provided for:
CELL-DYN 1800
CELL-DYN 1700
CELL-DYN 1600*
CELL-DYN 1400*
CELL-DYN 1300*
CELL-DYN 1200

*assay values are provided for use outside of the United States.

Features:
7 Consecutive Day Open-Tube Stability
120 Days Closed Tube Stability (approximate)
Run in Open mode

List Number	Description	Size
99110-01	CELL-DYN Calibrator	2 x 2.5 mL Tubes

CELL-DYN 22 Control is a hematology whole blood, quality control material used to monitor results obtained on CELL-DYN hematology systems.

Assay values are provided for:
CELL–DYN Ruby**
CELL-DYN 3500/3700
CELL-DYN 3200
CELL–DYN 3000
CELL-DYN 1800
CELL-DYN 1700
CELL–DYN 1600*

*assay values are provided for use outside of the United States.
** assay values for CELL-DYN Ruby provided for use in counties/territories where the system is commercially available

Features:
8 Consecutive-Day Open-Tube Stability
85 Days Closed Tube Stability (approximate)

List Number	Description	Size
93111-01	CELL-DYN 22 Tri-Level Control (FULL PACK)	12 x 2.5 mL Tubes
99106-01	CELL-DYN HALF PACK Tri-Level Control	6 x 2.5 mL Tubes
99103-01	CELL-DYN NORMAL PACK (SINGLE LEVEL)	6 x 2.5 mL Tubes
01H91-01	CELL-DYN 22 CONTROL ASSAY DISK	1 disk

CELL-DYN 22 Calibrator is a whole blood calibrator used to calibrate CELL-DYN hematology systems. Calibration values are provided for WBC, RBC, HGB, MCV, and PLT parameters.

Assay values are provided for:
CELL–DYN Ruby**
CELL-DYN 3500/3700
CELL-DYN 3200
CELL–DYN 3000
CELL-DYN 1800
CELL-DYN 1700
CELL–DYN 1600*

*assay values for CELL_DYN 1600 provided for use outside the United States
** assay values for CELL-DYN Ruby provided for use in counties/territories where the system is commercially available

Features:
7 Consecutive-Day Open-Tube Stability
60 Days Closed Tube Stability (approximate)

List Number	Description	Size
99120-01	CELL-DYN 22 Whole Blood Calibrator	2 x 2.5 mL Tubes

CELL-DYN Retic Plus Control is a hematology whole blood quality control material to monitor reticulocyte values with both automated and manual counts.

Assay values are provided for:
CELL-DYN Ruby
CELL-DYN 4000
CELL-DYN 3700
CELL-DYN 3500
CELL-DYN 3200
Manual Count

Features:
14 Consecutive-Day Open-Vial Stability
75 Days Closed Tube Stability
Manual count comparison

List Number	Description	Size
08H62-01	CELL-DYN Retic Plus Control	10 x 3.0 mL Vials

CELL-DYN 29 Plus Control (with Retic) is a Whole Blood hematology quality control material used to monitor results obtained on CELL-DYN systems.

Assay values are provided for:
CELL-DYN Sapphire
CELL-DYN Ruby**
CELL-DYN 4000
CELL-DYN 3500/3700
CELL-DYN 3200

** assay values for CELL-DYN Ruby provided for use in counties/territories where the system is commercially available

Features:
7 Consecutive-Day Open-Vial Stability
75 Days Closed Tube Stability
Nucleated RBC values available for CELL-DYN Sapphire and CELL-DYN 4000

List Number	Description	Size
08H58-01	CELL-DYN 29 Plus Control (with Retic)	12 x 3.0 mL Vials
08H58-02	CELL-DYN 29 Plus Control (with Retic)	6 x 3.0 mL Vials
08H64-01	CELL-DYN 29 Plus Control Assay Disk	1 disk

CELL-DYN HemCal Plus Calibrator is a whole blood calibrator used to calibrate CELL-DYN hematology systems. Calibration values are provided for WBC, RBC, HGB, MCV, PLT and MPV parameters.

Assay values are provided for:
CELL-DYN Sapphire
CELL-DYN Ruby**
CELL-DYN 4000
CELL-DYN 3500/3700
CELL-DYN 3200

** assay values for CELL-DYN Ruby provided for use in counties/territories where the system is commercially available

Features:
5 Consecutive-Day Open-Vial Stability
35 Days Closed Tube Stability

List Number	Description	Size
08H57-01	CELL-DYN HemCal Plus Calibrator	2 x 3.0 mL Vials

The intended use of the CELL-DYN Immuno T-Cell (CD 3/4/8) Assay is to report the concentration and proportion of T-lymphocytes and associated T-Cell subsets in EDTA-anticoagulated human whole blood.

The Assay is intended for use on:
CELL-DYN Sapphire
CELL-DYN 4000 (software version 9.2 or greater)

Reagent kits are composed of:
CELL-DYN CD3/4 T-Cell Reagent, 20 tubes with oranges caps
CELL-DYN CD3/8 T-Cell Reagent, 20 tubes with green caps
Packaged in separate pouches with corresponding color coded labels.

Features:
Fully automated sampling and value calculations
Barcode labeled, color coded tubes for CD3/4 and CD3/8 reagents
60-Day Open Storage Pouch Stability
12 Month Closed Storage Pouch Stability
Individual tubes for each test
Special Calibration not required to run the T-Cell Assay

List Number	Description	Size
07H22-01	CELL-DYN Immuno T-Cell (CD 3/4/8) Reagents	20 tests

CELL-DYN ImmunoPlt (CD61) Reagent is a one-color direct immunofluorescence reagent for enumerating platelets (PLT) in human whole blood.

The assay is intended for use on:
CELL-DYN Sapphire
CELL-DYN 4000 (software version 8.2 or greater)

Features:
Fully automated sampling and value calculations
60-Day Open Storage Pouch Stability
12 Month Closed Storage Pouch Stability
Individual tubes for each test
Factory calibrated

List Number	Description	Size
03H05-01	CELL-DYN ImmunoPlt (CD61) Reagent	40 tests

List Number	Description
	CELL-DYN 16 Controls/Calibrator/Disk
99109-01	CD16 TRLVL CTL VT (12X2.5)
99105-01	CD16 CTRL HALF PACK
02H40-01	CD16 NRML CTL PAK (HALFPK)
99110-01	CD 16 CAL (2X2.5)
01H92-01	CD16 ASSAY DSK (EA)
	CELL-DYN 22 Controls/Calibrator/Disk
93111-01	CD22 FL TRIPAK CT (12X2.5)
99106-01	CD22 HF TRI PK CT (PACK)
99103-01	CD22 HLF NORM CTL (PACK)
08H62-01	CD RETIC PLUS (10X3ML)
99120-01	CD22 CALIBRATOR (2X2.5)
01H91-01	CD22 ASSAY DSK (EA)
	CELL-DYN 29 Controls/Calibrator/Disk
08H58-01	CD29PLS TRILVL QC (12X3ML)
08H48-02	CD29PLS QC 1/2PK (6X3ML)
08H57-01	CD HEMCAL PLUS (2X3ML)
08H64-01	CD29PLS ASSAY DSK (EA)
	Reagent Kits
03H05-01	CDS 4K/61 IMM PLT (20T)
07H22-01	CD T-CELL PANEL (40T)