M I C R O B I A L S O LU T I O N S

Microbial Solutions Shanghai 2020

Those who work in QC know that their job is more than a box to be checked, and that job can’t be done effectively without
confidence in the results they report. Tight timelines, regulatory demands, and stringent data integrity standards can make it
hard to focus on what’s really at stake in your QC process: the safety of your product and the lives of your patients.

Give your team and your patients the peace of mind they need. Choose microbial testing solutions that offer the efficiency,
objectivity, and accuracy necessary to confidently deliver a safe therapeutic on time, every time.

Our Microbial Solutions portfolio of Endosafe® endotoxin testing, Celsis® rapid microbial detection, and Accugenix® microbial
identification and strain typing products and services facilitate confident and objective decision making, ensuring the integrity of
your microbial data and minimizing the risk to your patients. Like you, patient safety is at the core of what we do.

Endosafe® Endotoxin Testing:

• Endosafe® nexgen-PTS™ • Endotoxin Testing Instrumentation
• Endosafe nexgen-MCS™
®
• Endotoxin Testing Software
• Endosafe Nexus™
®
• Contract Endotoxin Testing Services
• Endosafe LAL Cartridges
®
• LAL Reagents and Accessories

Celsis® Rapid Microbial Detection:

• Celsis® Advance II™ • Support Reagents and Consumables
• Celsis Accel
® ®
• Celsis® Accessories

Accugenix® Microbial Identification and Strain Typing:

• Microbial Identification Services • Axcess® MALDI-TOF System

E V E R Y S T E P O F T H E WAY
 Endosafe nexgen-PTS™
®

Product Line Product Code

Endosafe nexgen-PTS™ instrument
®

Ethernet cable
Endosafe nexgen-PTS™
® One-year warranty PTS150K
Power supply
USB cable adapter
Stylus

Zebra Symbol barcode scanner FGD-000012

Zebra printer paper PTS325

Endosafe nexgen-PTS™
®
Eppendorf® µL pipettor PTS700
Accessories
Blank cartridges (quantity 2) PTS200

nexgen-PTS™ protective reader case PTS609

Annual calibration certification serviced at Charles River PTS900

Annual calibration certification: Rush Expedite

Full service contract including annual calibration certification PTS900FS

Endosafe® nexgen-PTS™
IQ/OQ/PQ kit PTS902K
Service and Support
Installation including IQ/OQ/PQ at customer site PTS902S

On-demand repair services: Labor only PTS903

Annual calibration certification: On-site service PTS905

Annual calibration certification PTS500

IQ/OQ/PQ kit PTS502K

Endosafe -PTS™
®
Full service contract incl. annual calibration certification at CRL PTS500FS
Service and Support
On-demand repair services: Labor only PTS503

Annual calibration certification: Rush Expedite

For spare or replacement parts, such as power cables and adapters, please contact your customer service representative.
Note: For additional information regarding services for your Endosafe®-PTS™, refer to the Endosafe®-PTS™ End-of-Life Policy.
Note: We will no longer provide on-site full service contracts for the Endosafe®-PTS™(PTS100).

Page 2
 Endosafe nexgen-MCS™
®

Product Line Product Code

Endosafe nexgen-MCS™ instrument
®

Power supply MCS150K

Ethernet cable
One-year warranty

Endosafe® nexgen-MCS™ Endosafe® nexgen-MCS™ package

Endosafe® nexgen-MCS™ instrument
EndoScan-V™ software MCS650K
Power supply
Ethernet cable
One-year warranty

Eppendorf® 25 μL pipettor PTS700

Accessories Blank cartridges (quantity 2) PTS200

Zebra Symbol barcode scanner FGD-000016

IQ/OQ/PQ document MCS975

Installation including IQ/OQ/PQ service and kit MCS902

Endosafe® nexgen-MCS™ IQ/OQ/PQ kit MCS902K

Service and Support On-demand labor MCS903

Annual qualification service MCS900

Standard service contract including annual on-site qualification MCS905

Annual calibration certification: Rush Expedite

IQ/OQ/PQ document MCS575

IQ/OQ/PQ kit MCS502K

On-demand repair services: Labor only MCS503

Endosafe®-MCS™
Service and Support Annual qualification service MCS500

Standard service contract including annual on-site qualification MCS505

Annual calibration certification: Rush Expedite

For spare or replacement parts, such as power cables and adapters, please contact your customer service representative.
Note: For additional information regarding services for your Endosafe® -MCS™, refer to the Endosafe® -MCS™ End-of-Life Policy.

Page 3
 Endosafe Nexus™
®

Product Line Product Code

Nexus™ robotic system - 24 tube racks
nexgen-MCS™ instrument
Nexus™ integrated software MR65024K
Computer
Anti-static mat
Endosafe® Nexus™
Nexus™ robotic system - 32 tube racks
nexgen-MCS™ instrument
Nexus™ integrated software MR65032K
Computer
Anti-static mat

Anti-static/slip mat MR115

Sterilized conductive 300 μL tips case

MR300
Endosafe® Nexus™ Accessories (5,760 per case)

Sterilized conductive 1 mL tips case

MR1000
(3,840 per case)

Installation and qualification service MR902

Annual service and qualification service MR900

Full service contract including annual qualification MR905

Endosafe Nexus™
®
Annual full service contract MR500FS
Service and Support
(nexgen-MCS™) IQ/OQ/PQ kit MR902K

On-demand repair services: Labor only MR903

Annual service and qualification MR500

Nexus™ software validation package MR600

Annual Maintenance and qualification service MR500

Standard service contract including annual qualification MR505

Endosafe® Nexus™
Service and Support Full service contract including annual qualification MR500FS
(MCS™)
IQ/OQ/PQ kit MR502K

On-demand repair services: Labor only MR903

For spare or replacement parts, such as power cables and adapters, please contact your customer service representative.

Page 4
 Endosafe LAL Cartridges
®

Product Line Product Code

10 single packs of inhibition/enhancement screening cartridges
*
PTS220

Sensitivity EU/mL

0.1 PTS201F
10 single packs of cartridges
0.05 PTS2005F
(FDA-licensed)
0.01 PTS2001F

0.005 PTS20005F
Endosafe® LAL Cartridges
0.1 PTS201

10 single packs of cartridges *

0.05 PTS2005

0.01 PTS2001

0.05 PTS5505F
Multi-packs of 25 cartridges
5/pouch 0.01 PTS5501F
(FDA-licensed)
0.005 PTS55005F

Endosafe® Glucan Beta-Glucan cartridges*

RMMGS1000
Assay Cartridges (10/pack)

* Not licensed by the FDA

Page 5
 Endotoxin Testing Instrumentation
Product Line Product Code
BioTek incubating microplate reader
®
M200
(with 340, 405, 450, 490, 630 nm filters)
BioTek® Kinetic Plate Readers Universal test plate for BioTek® reader M400
and Accessories
BioTek® filter M500

BioTek® bulb M700

Recertification BioTek® (valid for one year) TS950

Annual qualification service TS500

BioTek® reader/software annual qualification with bulb TS500BF

Kinetic Plate Readers
Service and Support Microplate reader IQ/OQ/PQ (document only) TS550

Microplate reader installation with IQ/OQ/PQ on-site TS502

Kinetic reader service contract TS2700

Page 6
 Endotoxin Testing Software
Product Line Product Code
Endosafe® EndoScan-V™ software
(compatible with BioTek® and M1260
original Endosafe® and nexgen test instruments)
EndoScan-V™ Software
Endosafe® EndoScan-V™Client Manager M1261

EndoScan-V™ software validation package TS600

Charles River Cortex™ software M1600

Charles River Cortex™ license/device authorization

M1601
per Endosafe®-PTS™ (PTS100K) instrument

Charles River Cortex™ license/device authorization

M1602
per Endosafe® nexgen-PTS™ (PTS150K) instrument
Charles River Cortex™ Charles River Cortex™ license/device authorization
M1603
per Endosafe® MCS™ (MCS100K)

Charles River Cortex™ license/device authorization

M1604
per Endosafe® nexgen-MCS™ (MCS150K)

Charles River Cortex™ license/device authorization

M1605
for Plate Reader/Tube Reader

Charles River Cortex™ IQ/OQ service AMC502S

Service and Support

Page 7
 Contract Endotoxin Testing Services
Product Line Product Code
Product validation, one lot TS201

Product validation, one lot: Rush TS201R

Product Validation*
Product validation, three lots TS203

Product validation, three lots: Rush TS203R

Non-regulated, any method

Kinetic chromogenic (cartridge technology)
Routine Endotoxin Gel-clot TS700
Determination Kinetic chromogenic
Kinetic turbidimetric

Routine endotoxin determination, any method: Rush TS700R

Release or stability testing TBET1

Release Testing*
Product release or stability test: Rush TBET1R

Sample preparation, extraction or heat** TS700E

Sample Preparation
Sample preparation, extraction or heat: Rush **
TS700ER

Oven validation/testing of challenge vials (≤ 10 vials) TS203

Oven Depyrogenation Validation
Oven validation/testing of challenge vials (≥ 10 vials) TS203

Special Certificate of Analysis (COA) testing TCOA1

Special Certificate of Analysis (COA) testing: Rush TCOA1R

Additional Services On-site training† (per day) TS400

SOP and protocol writing (per hour) TS800

Quality agreement (per hour) QA100

* Product validation must be completed prior to finished product release or stability testing.
** If Charles River prepares the extraction or treats the sample, there is an additional price per sample.
† Travel expenses additional

For information regarding the Proficiency Test Program, email ptp.support@crl.com.

 LAL Reagents and Accessories
Product Line Product Code
Pack of 6 R19000
KTA2
50-test vial (5.2 mL) Case of 12 R19000
(used for kinetic testing only)
Box of 100 R19000

Sensitivity EU/mL

Pack of 6 R15015

0.015 Case of 12 R15015

Kinetic Turbidimetric LAL† Box of 100 R15015

KTA Pack of 6 R15003
50-test vial (5.2 mL)
Used for kinetic or gel clot assays 0.03 Case of 12 R15003

Box of 100 R15003

Pack of 6 R15006

0.06 Case of 12 R15006

Box of 100 R15006

Endochrome-K™ (256-test kit)

8 × 3.2 mL vials R1708K
2 × 10 ng control standard endotoxin
3 × 30 mL LAL reagent water

Endochrome-K™ Case of 10 R1710

Kinetic Chromogenic LAL †
3.2 mL vials Box of 100 R17100
(KCA)
Endpoint chromogenic kit (140 test kit)
5 × 1.4 mL vials of chromogenic LAL
1 × 10 mg vial of chromogenic substrate S-2423 R160K
2 × 2 ng vials of endotoxin
2 × 30 mL vials of LAL reagent water
1 × 15 mL 0.05 M vial of Tris buffer

† Reserves of LAL reagents and matching Control Standard Endotoxin (CSE) are offered for a period of one year.

Page 9
 Product Line Product Code
Sensitivity EU/mL

Pack of 6 R15015

0.015 Case of 12 R15015

Box of 100 R15015

Pack of 6 R15003

0.03 Case of 12 R15003

Box of 100 R15003

Gel-clot LAL Pack of 6 R15006

50-test vial (5.2 mL) 0.06 Case of 12 R15006

Box of 100 R15006

Pack of 6 R11012

0.125 Case of 12 R11012

Box of 100 R11012

Endosafe® Gel-Clot LAL**† Pack of 6 R11025

0.25 Case of 12 R11025

Box of 100 R11025

Pack of 6 R12003

0.03 Case of 12 R12003

Box of 100 R12003

Pack of 6 R12006

0.06 Case of 12 R12006

Gel-clot LAL Box of 100 R12006

10-test vial (1.2 mL) Pack of 6 R12012

0.125 Case of 12 R12012

Box of 100 R12012

Pack of 6 R12025

0.25 Case of 12 R12025

Box of 100 R12025

** Lot-specific Certificate of Analysis included when reagents are purchased together.

† Reserves of LAL reagents and matching Control Standard Endotoxin (CSE) are offered for a period of one year.

Page 10
 Product Line Product Code
Sensitivity EU/mL

Pack of 25 R13006
Endosafe® Gel-Clot LAL**† Gel-clot LAL single-test vial 0.06
Case of 50 R13006
(continued) (0.2 mL)
Pack of 25 R13012
0.125
Case of 50 R13012

Rapid single-test LAL vials

0.06 or 0.25 Case of 50 R13500
Rapid Single-Test LAL Vials* (0.2 mL)

Rapid positive product control Case of 50 PC200

Pack of 6 E110
CSE – 500 ng per vial**
Box of 100 E110
Control Standard Endotoxin
Pack of 6 E120
(CSE) E. coli CSE – 10 ng per vial**
Box of 100 E120

Positive control (for single test) Pack of 25 PC100

Reference Standard Endotoxin (RSE) RSE USP – 10,000 EU per vial E150

CXE Dilution Kit

Extended CSE (CXE) Dilution Kit ** 1 × 10 ng CSE E140
1 × 60 mL stabilizing solution
1 pack of 11 of 16 × 100 mm capped tubes

30 mL bottle (<0.001 EU/mL) Case of 12 W130

50 mL bottle (<0.001 EU/mL) Case of 12 W120

LAL Reagent Water***
100 mL bottle (<0.001 EU/mL) Case of 12 W110

500 mL bottle (<0.001 EU/mL) Pack of 6 W150

* This product line is not licensed by the FDA and may not be used for pharmaceutical release testing.
** Lot-specific Certificate of Analysis included via the Endosafe Customer Portal® when reagents are purchased together.
*** Certificate of Quality included via the Endosafe Customer Portal®.
† Reserves of LAL reagents and matching Control Standard Endotoxin (CSE) are offered for a period of one year.

Page 11
 Product Line Product Code
5 mL 0.25 M Tris buffer Pack of 6 BT101

30 mL 0.1 M Tris buffer Case of 12 BT103

5.5 mL 0.1 M Tris buffer Pack of 6 BT105

LAL Buffers* 30 mL 0.05 M Tris buffer Case of 12 BT106

4 mL 0.5 M MgSO4, 1 M Tris buffer Pack of 6 BC1000

5.2 mL endotoxin-specific buffer Pack of 6 BG120

30 mL bio-dispersing agent Case of 12 BD100

Case of 12 EVV10K
10,000 EU
Box of 100 EVV10K

Case of 12 EVV100K
100,000 EU
Endotoxin Indicators** Box of 100 EVV100K

1 Million EU Each EVV1M

2.5 Million EU Each EVV2.5M

10 Million EU Each EVV10M

10 × 75 mm capped flint glass tubes Box of 50 T100

10 × 75 mm flint glass tubes, in foil Box of 50 T200

13 × 100 mm borosilicate glass tubes, in foil Box of 50 T300

10 × 75 mm borosilicate glass tubes, in foil Box of 50 T400

8 × 75 mm borosilicate glass tubes Box of 50 T500

Tubes
18 × 150 mm borosilicate glass tubes, in foil Box of 14 T600

16 × 125 mm Box of 12 T900

16 × 90 mm screw-cap borosilicate glass tubes Box of 70 TL700

12 × 75 mm borosilicate glass tubes, in foil Box of 50 TL1000

10 × 75 mm screw-cap borosilicate glass tubes Box of 70 TL1200

* Please contact Technical Support before using buffers. Additional buffers are available for specific testing needs.
** For dry heat oven validations

Page 12
 Product Line Product Code
Pack of 10 P100
1 mL, in foil
Box of 50 P100

Pack of 10 P200
2 mL, in foil
Box of 50 P200
Depyrogenated Glass Pipettes
Pack of 10 P500
5 mL, in foil
Box of 50 P500

Pack of 10 P1000
10 mL, in foil
Box of 50 P1000

2-200 μL* Pack of 50 D100EA

Eppendorf® Pipette Tips 2-200 μL Pack of 100 D200

2-200 μL* Case of 1000 D1000

Each M9005
96-Well Endosafe® Plates** 96-well polystyrene plate (certified to 0.005 EU/mL)
Case of 50 M9005
* Certificate of Quality not included.
** Tissue culture treated.

Page 13
 Celsis Rapid Microbial Detection
®

Product Line Product Code

Celsis Advance II™ system
Celsis® Advance II.im software
Celsis Advance II™ USB-serial cable 7456004
Power supply
Cuvette rack
Reagent rack

Celsis Accel® system

Celsis® Accel.im software
Celsis Accel ® USB-serial cable 7460288
Power supply
Cuvette rack
Reagent drip tray

AMPiScreen® Pharma 400 assay kit RST400

Celsis® Reagents LumiScreen™ Health 100 assay kit 1230839

LumiScreen™ Health 600 assay kit 1230941

ATP positive control kit 1291483

Support Reagents Daily wash & rinse kit 1290142N

Monthly maintenance and cleaning kit 92828

Celsis® Qualified Sterisart® NF Septum 10 packages/case

with 4 cm dual-needle 2 disposables/ 16466CR-GSD
(for closed, septum-topped sample containers) package

Celsis® Qualified Sterisart® NF Septum 10 packages/case

with 5.2 cm dual-needle
2 disposables/ 16467CR-GSD
Celsis® Qualified Consumables (for openable top sample containers such as
ampoules, bottles, or bags) package

Celsis® Qualified Hardy Diagnostics Tryptic Soy Broth,

Pack of 20 CM1010
USP, 100 mL Septum Top Glass Vial

Celsis® Qualified Hardy Diagnostics Fluid Thioglycollate

Pack of 20 CM1015
Medium, USP, 100 mL Septum Top Glass Vial

Celsis® Sterility Equivalency (Membrane Filtration) - Report VAL4000EQ

Celsis Implementation &
®
Celsis® Sterility Method Suitability (Membrane Filtration) - Testing Service VAL5000MS
Validation Support
Celsis Sterility Method Suitability (Membrane Filtration) - Protocol
®
VAL5100MS

Page 14
 Product Line Product Code
Celsis priming cuvettes, 75 mm (1,000)
®
1280052

Celsis® assay cuvettes, 55mm (1,000) 1280139

150 mL containers (120 ct) 1280200

Pipette 20 - 200 μL 91184

Pipette 100 - 1000 μL 91192

Pipette 5 - 50μL 91200

Celsis® Accessories Cuvette rack 80 92080

ATP-free pipette tips, 200 µL (10 x 96 pcs) 93678

ATP-free pipette tips, 1,000 µL (10 x 100 pcs) 93686

Glass beads, 0.5 mm AS9001

Antifoam-B emulsion AS9003

Linear shaker, 115V AS128001K

Linear shaker, 230V AS128002K

Celsis Advance II™ On-demand repair services: Labor TSLABOR

Service and Support On-demand repair services: Travel TSTRAVEL

Celsis Advance™: On-site basic preventive maintenance only RD600B

Celsis Advance™: On-site standard RD600S

Celsis Advance™: On-site premier RD600P

On-Site Training (per day) TS0001

Celsis Accel : installation including IQ/OQ/PQ at customer site

®
TS0003
Additional Instruments
Celsis Advance II™: On-site basic preventive maintenance only RD700B
Service and Support
Celsis Advance II™: On-site standard RD700S

Celsis Advance II™: On-site premier RD700P

Celsis Accel®: On-site basic preventive maintenance only RD500B

Celsis Accel : On-site standard

®
RD500S

Celsis Accel®: On-site premier RD500P

Page 15
 Accugenix Microbial Identification Services
®

Product Line Product Turnaround Time Code

Same-day BacSeq-0

AccuGENX-ID® bacteria (16S 500bp) 1-day BacSeq-1

DNA sequencing of the 16S rRNA gene in bacteria 2-day BacSeq-2

5-day BacSeq-5

Same-day FunITS-0

AccuGENX-ID® fungi (ITS2) 1-day FunITS-1

AccuGENX-ID®
DNA sequencing of the ITS2 rRNA region in fungi 2-day FunITS-2

5-day FunITS-5

1-day PROSEQ-1
AccuGENX-ID® ProSeq
protein-coding gene sequencing for closely related
organism groups 5-day PROSEQ-5

Same-day AccuPRO-ID-0

AccuPRO-ID® MALDI-TOF microbial identification 1-day AccuPRO-ID-1

AccuPRO-ID®
service 2-day AccuPRO-ID-2

5-day AccuPRO-ID-5

Same-day AccuBLAST-0

AccuBLAST® AccuBLAST® analysis of 16S raw data sequence files 1-day AccuBLAST-1

2-day AccuBLAST-2

AccuGENX-ST sequence-based strain typing

®
5-day AccuGENX-ST-5

AccuGENX-ST® AccuGENX-XGST® multi-locus sequence-based strain typing 5-day AccuGENX-XGST-5

MLST assay development fee Inquire SP-STF-01-10

Page 16
 Axcess MALDI-TOF System
®

Product Line Product Code

Axcess MALDI Biotyper CM package
®

Starter kit for MALDI-TOF MS

Barcode scanner for MALDI Biotyper AXC550
Reference physiocare pack (tips and pipettes)
Software package MALDI Biotyper 4.0 SR1
MALDI SW security pack for SW 4.0

Axcess® MALDI-TOF System Axcess® MALDI Biotyper Smart CM package

The Smart CM package includes all the features and
accessories as the Axcess MALDI Biotyper CM package, AXC650
with the added benefit of a fast solid-state Bruker smartbeam®
laser and high performance vacuum system.

Annual fee for Axcess® renewals (year 2 and beyond) AXC2002

Bacterial test standard (BTS) AXC110

Matrix HCCA AXC150

Axcess® MALDI Biotyper-CM
MSP 96 steel target plate AXC9600
Reagents
MSP adapter for MALDI Biotarget AXC4800AD

MALDI Biotarget 96 disposable target plate 20/pk AXC9600D

Axcess® Startup Package

The Axcess® Startup Package is available with the initial Axcess® instrument purchase.
Required with Purchase AXC8000
It includes the Bruker IQ/OQ/PQ, Charles River SQ/MV, and Axcess® authorization and
licensing fee for one year.

Complete CARE AXC900

Complete CARE priority plus AXC1100

Annual service contract gold AXC1000

Annual OQ-PV with service agreement AXC400B

Axcess® Service and Support* Annual OQ-PV without service agreement AXC 404B

Warranty plus AXC700

On-Site Training (per day) TS200

Software qualification/methods validation AXC502

* Contact your Account Specialist to review coverage for each service package.

Page 17
Ordering Information
Charles River Microbial Solutions Shanghai Co., Ltd.
查士利华微生物应用技术（上海）有限公司

上海青浦区华隆路１７７７号Ｇ幢１０１

电话：０２１ ３９７３９８８８

Contact Information
Endosafe® customer service & sales: Accugenix® technical support:
sales-msshanghai@criver.cn accugenixshanghai-techsupport@criver.cn

Endosafe® Celsis ® technical support:

endocelsistechsupport@criver.cn

www.criver-microbial.cn © 2020, Charles River Laboratories International, Inc.