Doc #

Document Description

 
AIDs
Artwork
Assay
Assembly
Audit
External
Forms
Labels
Manuals
MSDS
NPC
Obsoletes
PBRs
Protocols
Release Notes
Reports
Specs
SOPs
Tech Bulletins
Validations



 

00036 

Hexanes 

 
 
00045
ddATP (Roche)  
 
00062
70/10/10 Matrix Solution  
 
00063
50% Acetonitrile/Water Solution  
 

00073 

PCR Primer - Forward

 
 

00074 

PCR Primer - Reverse w/Biotin

 
 

00080 

Magnetic Beads 

 
 

00090 

TFI, Chip with Metal Disk 

 
 

00094 

Adhesive, Disk 

 
 

00115 

TFI Chip Silanization 

 
 

00117 

TFI, Pouched SpectroCHIP™ 

 
 

00122 

TFI, Pouched SpectroCHIP™ 

 
 

00130 

96+5 Pad Chip Silanization 

 
 

00131 

96+5 Chip with Metal Disk 

 
 

00132 

Pouched SpectroCHIP™, 96+5 Pads 

 
 

00133 

SpectroCHIP™ 96 Elements 

 
 

00140 

384+10 Chip Silanization 

 
 

00141 

384 Chip w/Metal Disk 

   
 

00142 

Pouched SpectroCHIP™, 384+10 Pads 

   
 

00143 

SpectroCHIP™ 384 Elements 

   
 
00145
5-Pt Calibrant, Liquid    
   

00154 

96+5 Pad SpectroCHIP™ Silanization (TFI) 

   
   

00155 

Pouched SpectroCHIP™, 96+5 Pads (TFI) 

   
   

00156 

384+10 SpectroCHIP™ Silanization (TFI) 

   
   

00157 

Pouched SpectroCHIP™, 384+10 Pads (TFI) 

   
   

00160 

Piranha Solution Preparation 

   
   
00171
Artwork, SpectroJET™ v1.03b    
   
00175
Compact Disc (CD)    
   
00211
Artwork, SpectroJET™ v1.03b User's Guide    
   

00258 

Box, Reaction Component B 

   
   

00259 

Box, Reaction Component A 

   
   

00260 

Box, SpectroCHIP™ Pack 

   
   

00261 

Foam, Master Pack, w/Lid 

   
   

00262 

Shipper, Basic Kit 

   
   

00263 

Instructional Insert 

   
   

00264 

Reaction Components A 

   
   

00265 

Reaction Components B 

   
   

00266 

SpectroCHIP™ Kit 

   
   
00285
19" Monitor, Compaq S-910    
   

00302 

Artwork, Pouch Label

   
   

00303 

Artwork, Enzyme, Label

   
   

00304 

Artwork, PROBE Mix 1 Label 

   
   

00305 

Artwork, PROBE Mix 2 Label 

   
   

00306 

Artwork, PROBE Mix 3 Label 

   
   

00307 

Artwork, PROBE Mix 4 Label 

   
   

00308 

Artwork, PROBE Mix 5 Label

   
   

00309

Artwork, PROBE Mix 6 Label 

   
   

00310 

Artwork, Calibrant A, Label 

   
   

00311 

Artwork, Positive Control Primer Set 1, Label

   
   
00312
Artwork, Positive Control - PROBE Primer, Label    
   

00328 

PROBE Enzyme - ThermoSequenase™

   
   

00329 

PROBE Mix 1 

   
   

00330 

PROBE Mix 2 

   
   

00331 

PROBE Mix 3 

   
   

00332 

PROBE Mix 4 

   
   

00333 

PROBE Mix 5 

   
   

00334 

PROBE Mix 6 

   
   

00335 

Calibrant 

   
   

00336 

Positive Control Primer Set 1 

   
   
00337
EXTEND Primer    
   

00349 

Artwork, PROBE Mix 7 Label 

   
   

00350 

Artwork, PROBE Mix 8 Label 

   
   

00351 

Artwork, PROBE Mix 9 Label 

   
   

00352 

Artwork, PROBE Mix 10 Label 

   
   
00355
Artwork, Solution, 70/10/10 Matrix    
   

00363 

Label, ThermoSequenase™ Enzyme 

   
   

00401 

MULTIMEK™ 96 Pipetter 

   
   

00405 

Tip Conversion Kit 

   
   

00406 

Magnetic Lift w/Side Magnets 

   
   
00409
Monitor 15" Color    
   

00431 

MassARRAY™ Workstation 

   
   
00440
Compaq MassARRAY™ Workstation    
   

00468 

Tweezers, Type 1 Standard 

   
   

00474 

GeSIM Pump 

   
   

00478 

Lab Computer 

   
   

00479 

384+10 AZ Pad SpectroCHIP™, TFI 

   
   

00480 

Loctite Product 401 

   
   

00483 

Calibrant, Lyophilized 

   
   
00484
Box, SpectroCHIP™ 10 Pack    
   

00490 

384+10 SH Pad SpectroCHIP™ 

   
   

00492 

96+5 AZ Pad SpectroCHIP™, TFI 

   
   

00493 

96+5 SH Pad SpectroCHIP™ 

   
   

00495 

Loctite 401 

   
   
00510
Artwork, EXTEND Template    
   
00512
384+10 AZ Pad SpectroCHIP™ w/Fiducials, TFI    
   
00513
384+10 AZ Pad SpectroCHIP™ w/Fiducials, TFI    
   
00535
Label, Artwork, 3-Pt Calibrant, Lyophilized    
   

00579 

Label Artwork, SpectroCHIP™ 384 - (TFI) 

   
   
00616
3-Pt. Calibrant, Lyophilized    
   

00617 

EXTEND Enzyme 

   
   
00635
5-Pt Calibrant, Lyophilized    
   
00722
Artwork, MassARRAY RT Software v3.0.1 with Genotyping    
   
00723
Artwork, MassARRAY RT Software v3.0.1 No Barcode    
   
00771
Upgrade Kit, Nanodispenser S 1D Barcode    
   
01268
D384+10 SNP Discovery SpectroCHIP™ w/Data Matrix, PSI    
   
01269
D384+10 SNP Discovery Data Matrix    
   
01285
Artwork, MassARRAY™ SNP Discovery RT v1.1.0    
   
10000
BioMASS PROBE Basic Kit Instructions    
   
10031
hME Buffer    
   

10100 

PROBE Mix 7 

   
   

10101 

PROBE Mix 8 

   
   

10102 

PROBE Mix 9 

   
   

10103 

PROBE Mix 10 

   
   
10104
Positive Control, EXTEND Template - sME    
   

10200 

Enzyme Pack 

   
   
10591
MassARRAY™ TRACKER Prep Assembly    
   
11301
Server, MassARRAY™ OligoCHECK 7K System    
   
11308
Server, MassARRAY™ OligoCHECK 7K System, 240V    
   
11317
Server, Allelotyping 110V    
   
11318
Server, Allelotyping 220V    
   
11319
Upgrade, Allelotyping Server 110V/220V    
   
11403
SpectroJET™ v1.03b    
   
11404A
SpectroCHECK™ v1.3 Build 66 Registry Key Rework    
   
11405A
MassARRAY™ Assay Design v1.3.4 Registry Key Rework    
   
11406A
MassARRAY™ Genotype Analyzer v1.4.5 Registry Key Rework    
   
11412
SpectroTYPER™ RT v2.0    
   
11412A
SpectroTYPER™ RT v2.0 Registry Key Rework    
   

11413 

SpectroTYPER™ Software v1.4.5 Registry Key 

   
   
11422A
MassARRAY™ RT v2.0 r1.0 (autoflex®) Registry Key Rework    
   
11429
MassARRAY™ SNP Discovery RT v1.1.0    
   
11501
SpectroJET™ v1.03b User's Guide    
   
11529
MassARRAY™ RT Workstation CD V3.0.3    
   

12001 

GeSIM Pump, Silated Std 

   
   

12003 

Alignment Plate 

   
   

12004 

MTP Holder with Magnets 

   
   

12010 

MTP Holder, GeSIM 

   
   

12255 

UPS Compaq T-700

   
   
12256
19" Monitor, Compaq S-910    
   

12277 

Fuse, 5A 250V, 5 x 20 mM, Fast Acting

   
   
00229-000
Artwork, SpectroTYPER RT v2.0    
   
00229-001
Artwork, MassARRAY RT Software v3.0.0 with Allelotyping    
   
00229-002
Artwork, SpectroTYPER RT v2.0 with SpectroTRACKER    
   
00229-003
Artwork, SpectroTYPER RT v2.0 with Allelotyping and SpectroTRACKER    
   
0715-003
Inspection Record Fan Coil FC 0-1    
   
0715-004
Inspection Record Air Conditioner GE 05    
   
0715-005
Inspection Record Air Conditioner HP 1    
   
0715-006
Inspection Record Air Conditioner HP 2    
   
0715-007
Inspection Record Air Conditioner HP 3    
   
0715-008
Inspection Record Air Conditioner HP 4    
   
0715-009
Inspection Record Air Conditioner HP 6    
   
0715-010
Inspection Record Air Conditioner HP 7    
   
0715-011
Inspection Record Air Conditioner HP 8    
   
0715-012
Inspection Record Air Conditioner HP 9    
   
0715-013
Inspection Record Air Conditioner HP 10    
   
0715-014
Inspection Record Air Conditioner HP 11    
   
0715-015
Inspection Record Air Conditioner HP 12    
   
0715-016
Inspection Record Air Conditioner HP 13    
   
0715-017
Inspection Record Air Conditioner HP 14    
   
0715-018
Inspection Record Fan Coil FC 16    
   
0715-019
Inspection Record Fan Coil FC 17    
   
0715-020
Inspection Record Fan Coil FC 18    
   
0715-021
Inspection Record Fan Coil FC 23    
   
0715-022
Inspection Record Fan Coil FC 24    
   
0715-023
Inspection Record Fan Coil FC 25    
   
0715-024
Inspection Record Fan Coil FC 26    
   
0715-025
Inspection Record Fan Coil FC 28    
   
0715-026
Inspection Record Fan Coil FC 27    
   
0715-027
Inspection Record Fan Coil FC 30    
   
0715-028
Inspection Record Fan Coil FC 36    
   
0715-029
Inspection Record Steam Humidifier 1    
   
0715-030
Inspection Record Mechanical Boiler 1    
   
0745-006
Pipette Repair Request    
   
0745-019
Calibration Stamp Control    
   
0745-021
Calibration Procedure for Immersion Type Thermometers    
   
0815-002
Material Requisition Project Related Item Usage    
   
0845-003
New Item Release in BaaN    
   
1006-004
M020-30-04 Plan Module (request hard copy from QA)    
   
1006-015
M020-30-15 Move Rack Module    
   
1006-023
M020-30-23 Dispense Aliquots on Plate Module    
   
1006-024
M020-30-24 Assay Assignment Module    
   
1006-025
M020-30-25 Create BFILE Pointers    
   
1006-028
M020-30-28 Pooling Aliquots Module    
   
1015-002
Sequenom MassARRAY™ Workstation Hardware Qualification    
   
1015-005
Sequenom MassARRAY™ Workstation Compaq ML370 Proliant Hardware Qualification    
   
1015-010
SpectroTYPER™ RT Hardware Installation and Setup    
   
1015-011
Image Installation for SpectroTYPER™ RT    
   
1015-014
SpectroTYPER™ RT Configuration    
   
1015-015
Sequenom Workstation Hardware Qualification    
   
1015-019
Compaq ML370 G2 SpectroTYPER™ Server Hardware Qualification    
   
1015-020
Compaq ML370 G2 SpectroTYPER™ Server Configuration Procedure    
   
1056-002
SpectroJET™ v1.03b Release Notes    
   
1056-008
MassARRAY™ Discovery-RT Software v1.1 Alpha Release Notes    
   
1056-010
SNP Discovery Release Notes    
   
1056-013
Multimek Install Disk, hMC SNP DISCOVERY, PN 11433, Liquid Handler SNP Discovery Macros v2.0.2    
   
1056-017
MassARRAY™ Services v1.2.1    
   
1057-005
LIMS User's Guide v1    
   
1075-002
MassARRAY™ 200K LIMS Interface Training Guide    
   
11412-000
SpectroTYPER RT v2.0    
   
11412-001
MassARRAY RT Software v3.0.0 with Allelotyping    
   
11412-001A
MassARRAY RT Software v3.0.0 Registry Key Rework    
   
11412-002
SpectroTYPER RT v2.0 with SpectroTRACKER    
   
11412-003
SpectroTYPER RT v2.0 with Allelotyping and SpectroTRACKER    
   
11437-000
MassARRAY RT Software v3.0.1 with Allelotyping    
   
11437-001
MassARRAY RT Software v3.0.1 with Genotyping    
   
11437-002
MassARRAY RT Software v3.0.1 No Barcode    
   
2005-010
Site Requirements for the MassARRAY System    
   
2015-018
Customer Complaint Form    
   
2065-002
Customer Complaint Handling    
   
3005-001
Plate Oligos    
   
3005-071
Abgene Plate Tracking Height    
   
3045-049
Sealing and Shipping AB0862 Oligo Plates    
   
3045-091
Microsoft Excel Processing of SPECTRAmax Data    
   

4045-015

SNP Pipeline (Pooled Template) PROBE Reaction Processing for 96-Well Plates using MULTIMEK™ 

   
   

4045-016

Preparation of EXTEND Cocktail for 96-Well Plate 

   
   

4045-018

SNP Validation (Individual) EXTEND Reaction Processing for 96-Well Plates using MULTIMEK™ 

   
   

4045-019

4-Channel GeSIM Nanoplotter Operation for Dispensing of EXTEND Products 

   
   

4045-021

Double Termination EXTEND Cocktail 

   
   

4045-022

Triple Termination EXTEND Cocktail 

   
   

4045-026

Single Termination EXTEND Cocktail 

   
   
5015-019
Part History    
   
5015-032
Office Depot Order Form    
   

5045-001 

Part History File Procedure

   
   
5045-056
Expired Materials Process    
   
60-10500
MassARRAY System 96    
   
60-10510
MassARRAY Jet System B384 120V    
   
6005-002
SpectroCHIP™ Fabrication - TFI    
   

6045-032

Disk/Chip Gluing 

   
   

6045-033

SpectroCHIP™ Silanation SOP 

   
   
6045-076
Shop Order Procedure    
   

7005-024

Records Retention Schedule 

   
   
7005-027
Interface Control Working Group (ICWG)    
   
7005-038
New Hire Orientation    
   
7015-006
Training Information Form    
   
7015-007
Training Feedback Form    
   
7015-029
Brinkmann Repair Request    
   
7015-030
Interface Control Request (ICR) Sequenom®, Inc/Integrated DNA Technologies®, Inc.    
   
7035-001
SEQUENOM Mission Statement    
   
7035-002
Receiving Inspection Policy    
   
7035-004
Finished Goods Inspection Policy    
   
7035-005
Finished Goods Inspection SOP    
   
7045-003
Management of Change    
   
7045-004
Employee Training    
   
7045-005
Thermal Cycler Evaluation SOP    
   
7045-006
Electronic Routing/Review of Controlled Documents    
   
7045-007
Good Documentation Practices    
   
7045-016
Engineering Release    
   

7045-019

New Product Commercialization 

   
   
7045-020
Control of Inspection, Measuring and Test Equipment     
   
7045-029
Using the Equipment Database (Training Aid)    
   
7045-031
Brinkmann Repair Request    
   
7045-032
Interface Control    
   
7045-042
Routing Procedure for Change Control Board (CCB) Documents    
   
8045-013
High Performance Liquid Chromatography (HPLC) Method    
   
8045-014
HPLC Method for Determining Ammonium Citrate & 3-HPA Concentration in MALDI Matrix Samples    
   
8701-001
CFTR (Cystic Fibrosis Transmembrane Regulator) 3 MassEXTEND™ Primer hME Assay Design 1.3    
   
8701-002
ACE-I/D (Angiotensin-converting Enzyme - Insertion/Deletion) hME Assay Design    
   
8701-003
HPA1 (GPIIIa) hME Assay Design    
   
8701-004
PAI1 hME Assay Design    
   
8701-005
Angiotensin I (AGT) - M235T Mutation hME Assay Design    
   
8701-006
Hemochromatosis (HFE) - H63D and C282Y Mutations hME Biplex Assay Design    
   
8701-007
FV (F5) R506Q Mutation (FV Leiden)    
   
8701-008
F7-R353Q mutation hME™ Uniplex Assay Design    
   
8701-009
Fibrinogen (FGB) -455 (G/A) Mutation hME™ Assay Design    
   
8701-010
CFTR (Cystic Fibrosis Transmembrane Regulator) ACMG Full Panel hME™ Assay Design 1.0 Manually Designed    
   
8701-011
CCR5-32 mutation hME™ Uniplex Assay Design    
   
8701-012
Canavan Disease - Y231X, E285A, and A305E mutations hME™ Triplex Assay Design    
   
8701-013
Niemann-Pick Disease - R496L, L302P, and fsP330, mutations hME™ Triplex Assay Design    
   
8701-014
HBB- codon 5,6 & 26 mutations hME™ Biplex Assay Design    
   
8701-015
Mucolipidosis Type IV del6.4kb and 5534a>g, mutations hME™ Biplex Assay Design    
   
8701-016
Alpha-1 Antitrypsin (AAT) - E342K and E264V Mutations hME™ Biplex Assay Design    
   
8701-017
Gaucher Disease L444P, IVS2+1g>a, N370S, 84g>gg, and R496H, mutations hME™ 3-Biplex Assay Design    
   
8701-018
Familial Dysautonomia, 76835a>g mutation hME™ Uniplex Assay Design    
   
8701-019
Fanconi Anemia, IVS4+4a>t mutation, and Bloom Syndrome BLMAsh mutation hME™ Biplex Assay Design    
   
8701-020
APOAV (ApolipoproteinAV) hME™ Assay Design 1.0 SpectroDESIGNER™    
   
8701-021
Factor II hME™ Assay Design    
   
8701-022
Cystic Fibrosis G542X, N1303K, 508delF, W1282X, and 3849+10Kb c>t, mutations hME™ 3- Biplex Assay Design    
   
8857-002
HTP hME SpectroPREP™ Installation Guide v2.0    
   
8857-003
HTP hME SpectroPREP™ Installation Guide v2.0    
   
95-00147
MSDS Shrimp Alkaline Phosphatase    
   
95-00337
MSDS    
   

95-00617

EXTEND Enzyme 

   
   
95-00635
MSDS for 00635 5-Pt Calibrant    
   
95-10104
MSDS    
   
CRDART00001
Artwork, Non-Conforming Material Tag    
   
CRDFRM00001
Field Service/Installation Report    
   
CRDSPC00001
Non-Conforming Material Tag    
   

GBUFRM0001

Subject Information and Consent Form for BMR

   
   
GBUFRM0002
Data Collection Form    
   
GBUFRM0007
Data Collection Form (Short)    
   
GBUFRM0008
Data Collection Form (II)    
   
GBUSOP00003
DNA Standard Preparation    
   
GBUSOP00002
PicoGreen Working Solution    
   
GBUSOP00004
DNA Measuring    
   
GBUSOP00005
DNA Dilution    
   
GBUSOP00007
DNA Banking Database    
   
GBUSOP00011
Gowning Procedure for Room 118    
   
GBUSOP00012
Gowning Procedure for Rooms 120 and 121B    
   
MFGDWG00012
Partial Count    
   
MFGFRM00001
Part Number Change Request    
   
MFGFRM00003
Cocktail Request Form    
   
MFGFRM00005
Special Formulation Batch Record    
   
MFGFRM00006
Chemical Receiving Information Record Form    
   
MFGFRM00009
Raw Material Receiving Inspection Form    
   
MFGFRM00016
Non-Conforming Materials Report    
   
MFGLST00001
Basic Kit Product Name    
   
MFGLST00002
Basic Kit Composition    
   
MFGLST00003
Basic System Plus - BOM (US Version)    
   
MFGPBR00002
0.7M Ammonium Citrate Solution    
   
MFGPBR00003
0.07M Ammonium Citrate Solution    
   
MFGPBR00005
50 mM Ammonium Hydroxide HN4OH    
   
MFGPBR00008
10 mM Tris - HC1, pH 8.0    
   
MFGPBR00026
10X PROBE Buffer    
   
MFGPBR00028
5M Sodium Hydroxide (NaOH)    
   
MFGPBR00038
2.0M Ammonium Chloride Solution    
   
MFGPBR00039
1.0M Ammonium Chloride Solution    
   
MFGPBR00057
3.0M Ammonium Chloride Solution    
   
MFGPBR00058
10 mM Sodium Hydroxide (NaOH)    
   
MFGPBR00064
10X Tris - EDTA    
   
MFGPBR00069
0.1M Sodium Hydroxide (NaOH)    
   
MFGPBR00086
2.1M Ammonium Citrate Solution    
   
MFGSAF00336
MSDS For Positive Control - Primers Set 1    
   
MFGSOP00001
Matrix Formulation    
   
MFGSOP00002
APL PCR Reagent Cocktail Formulation    
   
MFGSOP00003
PROBE Reaction Cocktail    
   
MFGSOP00005
PROBE Buffer    
   
MFGSOP00006
0.7 and 0.07M Ammonium Citrate Formulation    
   
MFGSOP00007
0.07M Ammonium Citrate Formulation    
   
MFGSOP00008
1M, 100 mM and 10 mM Tris - HC1    
   
MFGSOP00009
500 mM and 50 mM Ammonium Hydroxide Formulation    
   
MFGSOP00010
2M NH4C1 Formulation    
   
MFGSOP00011
1M, 2M and 3M NH4C1 Formulation    
   
MFGSOP00012
Deoxinucleotide Dilution    
   
MFGSOP00013
DynaBeads Preparation    
   
MFGSOP00014
Oligonucleotide Dilution    
   
MFGSOP00017
Mass SpectroMETER™ Calibrant Mixture    
   
MFGSOP00018
10M, 5M, 1M, 0.1M and 10 mM Sodium Hydroxide    
   
MFGSOP00023
White Blood Cell Lysis Buffer    
   
MFGSOP00024
Red Blood Cell Lysis Buffer    
   
MFGSOP00025
Tris EDTA Buffer (10X & 1X)    
   
MFGSOP00026
2.1 M Ammonium Citrate Formulation    
   
MFGSOP00030
Positive Control - PROBE Primer    
   
MFGSOP00031
Positive Control - Primers Set 1    
   
MFGSOP00035
SpectroCHIP™ Pouching    
   
MFGSOP00039
1M Tris - HC1, pH 9.5    
   
MFGSOP00040
PROBE Mix    
   
MFGSOP00056
Positive Control - PROBE Primer    
   
MFGSOP00059
Oligonucleotide Preparation    
   
MFGSPC00346
Artwork, Shipping Label    
   
QADFRM00002
Controlled Document Receipt Acknowledgment    
   
QADLST00001
Signature Authority Matrix    
   
QADSOP00016
Lot Numbering Procedure    
   
RESSOP00002
GeSIM Cleaning SOP    
   
RESSOP00009
Tecan Genesis Series Maintenance SOP    

 
4005-001
Sequence Format Specifications 09/08/00  

 
3005-053
Naming Convention of Plates 02/27/02  
 
3005-039
Standard Preparation Protocol 02/27/02  
 
3005-042
Diluting Protocol 02/27/02  
 
3005-043
Fluoroskan Measuring Protocol 02/27/02  
 
3005-044
Pooling DNA 02/27/02  
 
3005-045
Ordering Protocol 02/27/02  
 
3005-051
Magnetic Beads Preparation 02/27/02  
 
3005-072
SPECTRApivot (electronic copy) 04/10/02  
 
3005-047
Centrifuging Samples 02/26/02  
 
3005-048
Sealing Plates 02/26/02  
 
3005-049
Vortexing Samples 02/26/02  
 
3005-052
Hydra AW Program Log 02/27/02  
 
E3005-054
Syringe Changes on 384-Head 02/14/02