Roche cobas 8000 / ISE Module User guide

Accessories, consumables, auxiliaries and ISE catalogue

CPS Serum Work Area Systems

Publication

version

Revision

date Change description

1.0 01-2020 • First Version

1.1 02-2020 • Inclusion of cobas e 801 and cobas c 513 for the Micro Sample Cup

• Correction of typos

2.0 11-2020 • Inclusion of products compatible with cobas

®

pure integrated

solutions

• Inclusion of list with different rack ranges

• Addition of different diluents not listed in the ﬁrst version

• New category: Legal Manufacturer

• Sample containers pictures in the correct position

• New TSH products for Instrument Check

• Pack size update for Sample Cup, Sample Cup Micro 13

• Addition of racks for the cobas c 513

• Addition of 4 COBAS INTEGRA

®

400 products not listed in the ﬁrst

version

• Terminology update

• Inclusion of 3 consumables not listed in the ﬁrst version

• Inclusion of START for cobas c 701 / 702

• General wording update

3

.0 05-2021 • Removal of COBAS INTEGRA

®

Vial & Cap Kit (Phase out)

• Removal of cobas e 801 and cobas e 402 for the CalSet TSH for

Instrument Check

• Addition of new main categories Others and Service use only and

corresponding rearrangement

•

Adapation of Replacement Frequency for the racks and tube adapter

• Removal of shelf life

• Terminology update

• Correction of typos

• General wording update

Updates

Accessories, consumables, auxiliary reagents

and ISE reagents in this catalogue are

essential components for the correct use

of SWA Systems*.

T

his marketing catalogue contains guidance on usage and

hints to sources of additional information. You can find

the link to eLabDoc, product pictures and package

information.

This is a document with relevant content about items used in

combination with the following instruments:

cobas

®

4000 analyzer series, cobas

®

6000 analyzer series,

cobas

®

8000 modular analyzer series, cobas

®

pro

integrated solutions, cobas c 513 analyzer, COBAS

INTEGRA

®

400 plus analyzer and cobas c 111 analyzer.

* cobas c 111 analyzer is now part of the Point of Care,

Clinical Chemistry & Immunoassay lifecycle team.

Introduction

is glossary gives more details about the content of

the product pages. All items covered in this catalogue

contain the same list of features as below:

Header

Simple description of what the product is

Compatible instruments

List of instruments on which the product can be used

Location for use

Where on the instrument the product will be used

Product registration on instrument

How does the system recognize the product onboard

Replacement frequency

How often is the product normally replaced

Product labeling

What labeling materials are included in the package

Onboard stability

How long is the product stable on the instrument

Pack size

What is included in a single selling unit of the product

Legal manufacturer

Legal entity responsible for the product

Glossary

Updates

Introduction

Glossary

Accessories

Sample containers

Sample Cup ..................................................7

Sample Cup Micro 13 / 16

................................ 8

cobas

®

cup ..................................................9

Micro-Sample Cup

....................................... 10

RD Standard False Bottom Tube

.................... 11

Empty reagent carrier

MULTI ................................................... 12, 13

Closed Development Channel – CDC

.... 14, 15, 16

CalSet Vials

................................................. 17

ControlSet Vials

........................................... 18

Disposable Elecsys

®

Wasteliner M ............................................... 19

AssayTip / AssayCup

..................................... 20

AssayCup

.................................................... 21

AssayTip

..................................................... 22

Clean-Liner

................................................. 23

AssayTip / AssayCup tray

............................... 24

Wasteliner

................................................... 25

Consumables Storage Box

............................ 26

13 mm sample disk tube adapter

................... 27

Reaction vessels

Micro Cuvette Segment ................................ 28

Cuvette COBAS INTEGRA

®

............................ 29

Reaction bottle unit (Reaction Cell)

................ 30

Reaction Cell for cobas c 501 / cobas c 502

... 31

Reaction Cell for cobas c 503 / cobas c 513

... 32

Reaction Cell for cobas c 311

....................... 33

Reaction Cell for cobas c 303

....................... 34

Others

Chimney ..................................................... 35

Waste Container

.......................................... 36

Opening Tool

............................................... 37

Racks

Standard Sample Rack ............................38, 39

Standard Rack Calibration

....................... 40, 41

Standard Rack Control

............................ 42, 43

Standard Rack Re-run

.............................44, 45

Standard Rack STAT

................................ 46, 47

Standard Rack Wash

.................................... 48

HHT CTS QC Rack

....................................... 49

HHT CTS Rack

........................................ 50, 51

Green Wash rack

......................................... 52

Special Cell Cleaning Solution – SCCS

SCCS (Special Cell Cleaning Solution) ....53, 54, 55

Hemolysis Solution for HbA1c

A1CD2 – Hemolyzing Reagent Gen.2 .............. 56

A1CD – Hemolyzing reagent

..................... 57, 58

Hemolyzing Reagent Gen.2

........................... 59

A1CD2

........................................................ 60

NACL (Diluent) & Serum / Sample Index (SI2)

NaCl Diluent 9 % .................................... 61, 62

NACL – Diluent NaCl 9 %

....................63, 64, 65

SI2 – Serum Index Gen.2

..................... 66, 67, 68

Sample Cleaner (acid and basic)

Sample Cleaner 1 .................................... 69, 70

Sample Cleaner 2

.................................... 71, 72

NaOH (NaOHD and NaOH)

CLEAN .................................................. 73, 74

Cell Wash Solution I / NaOH-D

.................. 75, 76

Basic Wash

................................................. 77

NAOHD – Detergent 1

........................78, 79, 80

Cleaner

....................................................... 81

EcoTergent

ECO-D – EcoTergent .................... 82, 83, 84, 85

Acid Wash

Cell Wash Solution II / Acid Wash ................... 86

Acid Wash

................................................... 87

Selective mode solution

SMS – Detergent 2 .............................88, 89, 90

Others – clinical chemistry

START – Antigen Excess Reagent.............. 91, 92

Elecsys

®

PreClean M ................................................. 93

ProbeWash M

.............................................. 94

Content

Content page 2

CleanCell M ................................................ 95

ProCell M

.................................................... 96

ProCell II M

................................................. 97

PreClean II M

.............................................. 98

CleanCell

.................................................... 99

ProCell

..................................................... 100

Elecsys

®

SysWash ...................................... 101

Diluent Universal 2

..................................... 102

Diluent MultiAssay

...............................103, 104

Diluent Universal

.......................... 105, 106, 107

ISE - Devices

ISE -Devices – Electrodes – COBAS

INTEGRA

®

400 plus

Cl

-

Electrode .............................................. 108

Cl

-

Electrode Gen.2 .................................... 109

K

+

Electrode ...............................................110

Na

+

Electrode ............................................. 111

Reference Electrode

....................................112

Li

+

Electrode ..............................................113

Dummy electrode – Integra

..........................114

ISE- Devices – Electrodes

REF Electrode .............................................115

Cl Electrode

...............................................116

Na Electrode

..............................................117

K Electrode

................................................118

ISE- Devices – Electrodes cobas c 111

ISE Chloride Electrode ................................. 119

ISE Potassium Electrode

............................. 120

ISE Sodium Electrode

................................. 121

ISE Reference Electrode

............................. 122

ISE Dummy Electrode

................................. 123

I

SE - Accessories - Calibrators

ISE Calibration Kit ...................................... 124

ISE Standard Low

....................................... 125

ISE Standard High

...................................... 126

Activator Bottle Set

.................................... 127

ISE Solution 1

............................................ 128

ISE Solution 2

............................................ 129

ISE Solution 3

............................................ 130

Internal Standard Insert – ISE

..................... 131

ISE - Accessories - Reagents

ISE Reference Electrolyte ............................ 132

ISE Calibrator direct ................................... 133

ISE Calibrator indirect / urine ....................... 134

ISE Deproteinizer

....................................... 135

ISE Etcher

................................................. 136

ISE - Accessories - Reagents

ISE Internal Standard Gen.2 .................. 137, 138

ISE Diluent Gen.2

.................................139, 140

ISE Reference Electrolyte

............... 141, 142, 143

Activator

................................................... 144

ISE Calibrator indirect / urine

....................... 145

ISE Reference Solution

............................... 146

ISE Etcher

..................................................147

ISE Deproteinizer

....................................... 148

ISE Cleaning Solution / Elecsys

®

SysClean ..... 149

Others

Screw Cap for False Bottom Tube

................... 150

PC / CC-CUPS

............................................ 151

Bottle Set for cobas

®

8000 ISE .................... 152

Bottle Set

.................................................. 153

Sys Bottle 2 Assy

....................................... 154

Sys-Clean Adapter

..................................... 155

Reservoir Cup Assy

.................................... 156

LFC Cup Assy

............................................ 157

PW LFC Cup Assy

...................................... 158

PW LFC Cup 2 Assy

.................................... 159

Cup-Adapter w/o Tube Rotation

................... 160

Mixed-bed resin MBH 100

.......................... 161

Rack Test Assy (cassette rack)

.................... 162

Service use only

Instrument Check and Carry-over

Needle Assessment

CONA

.......................................... 163, 164, 165

INSTC – Instrument Check

............. 166, 167, 168

Check Solution Sample

............................... 169

TSH for Instrument Check

.....................170, 171

CalSet TSH for Instrument Check

................. 172

HBQ Sample Set

........................................ 173

CellCheck II

............................................... 174

SAP II

....................................................... 175

BlankCell High

........................................... 176

BlankCell

.................................................. 177

SAP Test

................................................... 178

CellCheck

................................................. 179

Content

Content page 1

Accessories » Sample containers

Compatible instruments

COBAS INTEGRA

®

400 plus, MPA, cobas c 111,

cobas c 311, cobas c 501, cobas c 502,

cobas c 503, cobas c 701, cobas c 702,

cobas e 411 (rack and disk), cobas e 601,

cobas e 602, cobas e 801, cobas c 303,

cobas e 402

Location for use

Depending on the system, the sample cup

will be loaded directly onto a rack or sample

disk. It can also be used as cup on tube in a

16 mm primary sample tube.

Product registration on instrument

Automatic detection with the height detection.

For COBAS INTEGRA

®

: This sample cup

needs an adapter and the combination needs

to be manually deﬁned.

Replacement frequency

Single use only.

Product labeling

Method sheet available and not included in

the package.

Onboa

rd stability

Not applicable.

Pack size

1 box contains 20 bags of 250 units each.

5,000 units.

Legal manufacturer

Roche Diagnostics GmbH

Sample container used for sample, calibrator and QC material.

Sample Cup

Global: 10394246001

Accessories » Sample containers

Compatible instruments

COBAS INTEGRA

®

400 plus, cobas c 111,

cobas c 311, cobas c 501, cobas c 502,

cobas c 503, cobas c 701, cobas c 702,

cobas t 511, cobas t 711, cobas c 303,

cobas e 402

Location for use

Depending on the system, the Sample Cup

Micro 13 / 16 will be loaded directly onto a

rack or sample disk. It can also be used as

cup on tube in a 16 mm primary sample tube.

For cobas c 111 and COBAS INTEGRA

®

: this

sample cup needs an adapter.

Product registration on instrument

Automatic detection with height detection.

For COBAS INTEGRA

®

: This sample cup

needs an adapter and the combination needs

to be manually deﬁned.

Replacement frequency

Single use only.

Product labeling

No method sheet available for this product.

Onboard stability

Not applicable.

Pack size

1 box contains 2 bags of 450 pieces each.

Legal manufacturer

Roche Diagnostics GmbH

e Sample Cup Micro 13 / 16 consumable is a container used for

sample material. e Sample Cup Micro has less dead volume

and is especially used when little sample material is available.

Sample Cup Micro 13 / 16

Global: 05085713001

Accessories » Sample containers

Compatible instruments

COBAS INTEGRA

®

400 plus

Location for use

It has to be used with an adapter.

Product registration on instrument

cobas

®

cup on adapter is pre deﬁned. The

assignment to the rack must be manually

deﬁned. Therefore, automatic detection by

the analyzer is possible.

Replacement frequency

Single use only.

Product labeling

No method sheet available for this product.

Onboard stability

Not applicable.

Pack size

1 bag with 1,000 units.

Legal manufacturer

Roche Diagnostics GmbH

e cup with hole is a container used for sample, calibrator

and QC material. e cup with hole has less dead volume and

is especially used when little sample material is available. Both

colors are the same and customers can use as they wish.

cobas

®

cup

cobas® cup white: 21045318001 / cobas® cup blue: 21044869001

Accessories » Sample containers

Compatible instruments

cobas c 501, cobas c 502, cobas c 701,

cobas c 513, ISE, cobas e 801, cobas

c 503, cobas c 303, cobas e 402

Location for use

The Micro-Sample Cup will be loaded

directly onto a rack with stabilizers. It can

also be used as cup on tube in a 16 mm

primary sample tube.

Product registration on instrument

Automatic detection by the height detection.

Replacement frequency

Single use only.

Product labeling

No method sheet available for this product.

Onboard stability

Not applicable.

Pack size

1 bag with 100 units.

Legal manufacturer

Hitachi High-Tech Corporation

e Micro-Sample Cup is a container used for sample material.

e Micro-Sample Cup has less dead volume and is especially

used when little sample material is available.

Micro-Sample Cup

Global: 11229290001

Accessories » Sample containers

Compatible instruments

cobas c 111, cobas c 311, cobas c 501,

cobas c 502, cobas c 503, cobas c 701,

cobas c 702, cobas e 411, cobas e 601,

cobas e 602, cobas e 801, cobas c 303,

cobas e 402

Location for use

RD Standard false bottom tube can be

directly loaded onto a rack or sample disk.

Product registration on instrument

Set up should be done on the SW by RSR

and special racks should be assigned.

Replacement frequency

Single use only.

Product labeling

Method sheet available and not included in

the package.

Onboard stability

Not applicable.

Pack size

1 box has 2 bags of 1,000 units each.

Legal manufacturer

Roche Diagnostics GmbH

e RD Standard False Bottom Tube is a disposable plastic tube

that has a threaded neck for closure with screw caps.

RD Standard False Bottom Tube

Global: 04740955001

Accessories » Empty reagent carrier

Compatible instruments

COBAS INTEGRA

®

400 plus, cobas c 311,

cobas c 501, cobas c 502

Location for use

cobas c pack MULTI is loaded onto the

instrument at assigned test position. For

COBAS INTEGRA

®

, there is no assigned

position.

Product registration on instrument

2D barcode.

Replacement frequency

Single use only.

Product labeling

Method sheet available and not included in

the package.

Onbo

ard stability

Onboard stability depends on the reagents

used in the reagent cassettes.

Pack size

Single cobas c pack.

Legal manufacturer

Roche Diagnostics GmbH

e empty cobas MULTI packs are intended for use as IVD

accessories for third-party clinical chemistry reagents to perform

non-Roche photometric applications.

MULTI

Global: 04593138190

Accessories » Empty reagent carrier

Compatible instruments

cobas c 701, cobas c 702

Location for use

cobas c pack MULTI is loaded onto the

instrument at assigned test position.

Product registration on instrument

RFID.

Replacement frequency

Single use only.

Product labeling

Method sheet available and not included in

the package.

Onboar

d stability

Onboard stability depends on the reagents

used in the reagent cassettes.

Pack size

Single cobas c pack large.

Legal manufacturer

Roche Diagnostics GmbH

Empty reagent carrier for use on Roche / Hitachi

cobas c 701 / c 702 systems.

MULTI

Global: 05353025190 / APAC: 05353025214 / China: 05353025188

Accessories » Empty reagent carrier

Compatible instruments

cobas c 503, cobas c 303

Location for use

CDC is loaded into the instrument at

assigned test position.

Product registration on instrument

RFID.

Replacement frequency

Single use only.

Product labeling

Method sheet available and not included in

the package.

Onbo

ard stability

Onboard stability depends on the reagents

used in the reagent cassettes.

Pack size

Single cobas c pack green.

Legal manufacturer

Roche Diagnostics GmbH

e empty cobas c packs CDCnn are intended for use as

IVD accessories for third-party clinical chemistry reagents to

perform non-Roche photometric applications on cobas c 503 /

cobas c 303 analytical units.

Closed Development Channel – CDC

Global: 08463115190, 08463123190, 08463140190, 08463158190, 08463166190,

08463182190, 08463204190, 08463212190, 08463239190, 08463247190,

09206795190, 09206809190, 09206817190, 09206825190, 09206841190

Accessories » Empty reagent carrier

Closed Development Channel – CDC

Gl

obal: 06300138190, 06300219190, 06300227190, 06300235190, 06300243190,

06300251190, 06300260190, 06300278190, 06300286190, 06300294190

Compatible instruments

cobas c 701, cobas c 702

Location for use

CDC is loaded into the instrument at

assigned test position.

Product registration on instrument

RFID.

Replacement frequency

Single use only.

Product labeling

Method sheet available and not included in

the package.

O

nboard stability

Onboard stability depends on the reagents

used in the reagent cassettes.

Pack size

Single cobas c pack large.

Legal manufacturer

Roche Diagnostics GmbH

Empty reagent carrier for use on Roche / Hitachi

cobas c 701 / c 702 systems.

Accessories » Empty reagent carrier

Compatible instruments

cobas c 501, cobas c 502

(last 5 material numbers only available

for the cobas c 502)

Location for use

CDC is loaded into the instrument at

assigned test position.

Product registration on instrument

2D barcode.

Replacement frequency

Single use only.

Product labeling

Method sheet available and not included in

the package.

O

nboard stability

Onboard stability depends on the reagents

used in the cassettes.

Pack size

Single cobas c pack.

Legal manufacturer

Roche Diagnostics GmbH

Empty reagent carrier for use on Roche / Hitachi cobas c systems.

Closed Development Channel – CDC

Global:

06483810190, 06483836190, 06483844190, 06483879190, 06483887190,

06483895190, 06483909190, 06483925190, 06483933190, 06483941190,

08036306190, 08036314190, 08036322190, 08041709190, 08041717190

Accessories » Empty reagent carrier

Compatible instruments

cobas e 411, cobas e 601, cobas e 602,

cobas e 801, cobas e 402

Location for use

Operator places the CalSet in a black

calibrator rack. For the cobas e 411, it’s

used in the grey rack.

Product registration on instrument

Detected by height detection automatically.

Replacement frequency

Each vial can be used in 4 calibration events.

Product labeling

No method sheet available for this product.

Onboard stability

Each and every vial can be used

up to 4 times.

Pack size

2 × 56 units.

Legal manufacturer

Roche Diagnostics GmbH

Empty SnapCap bottles. e CalSet Vials / ControlSet Vials are

used to aliquot the reconstituted or prelled Assay CalSets or QC

into smaller portions for storing.

CalSet Vials

Global: 11776576322

Accessories » Empty reagent carrier

Compatible instruments

cobas e 411, cobas e 601, cobas e 602,

cobas e 801, cobas e 402

Location for use

Operator places the ControlSet in a white

QC rack. For the cobas e 411, it’s used in the

grey rack.

Product registration on instrument

Detected by height detection automatically.

Replacement frequency

Single use only.

Product labeling

No method sheet available for this product.

Onboard stability

Each vial can be used in 4 QC events.

Pack size

2 × 56 units.

Legal manufacturer

Roche Diagnostics GmbH

Empty SnapCap bottles. e CalSet Vials / ControlSet Vials are

used to aliquot the reconstituted or prelled Assay CalSets or QC

into smaller portions for storing.

ControlSet Vials

Global: 03142949122

Accessories » Disposable Elecsys®

Compatible instruments

cobas e 601, cobas e 602

Location for use

Two Wasteliners are used alternately to

dispose used AssayTips and AssayCups.

Loaded in the front part of the instrument.

Product registration on instrument

Press the ﬂashing button on the magazine

waste compartment.

Replacement frequency

Depends on the number of tests done by the

laboratory. Each solid waste container holds

up to 8 magazines of tips and cups.

Product labeling

No method sheet available for this product.

Onboard stability

Not applicable.

Pack size

Set of 4 Wasteliners.

Legal manufacturer

Roche Diagnostics GmbH

e Wasteliner M is a single-use consumable intended to be used

as an IVD accessory for the cobas e 601 and cobas e 602.

Wasteliner M

Global: 03023150001

Accessories » Disposable Elecsys®

Compatible instruments

cobas e 601, cobas e 602

Location for use

The operator loads new magazines in the

front part of the instrument.

Product registration on instrument

Registered by the system automatically.

Replacement frequency

It depends on the amount of tests done

by the laboratory. The instrument holds a

maximum of 12 magazines, which represents

a maximum of 1,008 tests.

Product labeling

No method sheet available for this product.

Onboard stability

Not applicable.

Pack size

1 box contains 48 magazines (8 × 6) with

84 tips and 84 cups. 8 (2 × 4) solid waste

boxes are also included (Wasteliner M).

Legal manufacturer

Roche Diagnostics GmbH

e AssayTip / AssayCup is a single-use consumable intended

to be used as an IVD accessory for each patient test, calibration

and QC.

AssayTip / AssayCup

Global: 12102137001

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Roche cobas 8000 / ISE Module User guide

Roche cobas 8000 / ISE Module User guide

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