Specifications 5

Miscellaneous Engineering Specifications Functional Specifications Software Finished Goods Raw Materials 00009 - 00233 00236 - 00504 00550 - 11415 Spare Parts Beckman Bruker Nanodispenser RoboDesign Samsung Piezo Dispenser Used Parts	Doc #	Document Description	Rev #	Effective Date	AIDs Artwork Assay Audit External Forms Labels LIMS Manuals MSDS NPC Obsoletes PBRs Protocols Release Notes Reports Specs SOPs Tech Bulletins Validations
	*Assembly*
	00227	Cable Assembly, Signal	R03	02/13/02
	00228	Adapter, DB25 to BNC	R03	02/13/02
	00289	Genotyping Starter Kit, Room Temperature	R02	02/04/03
	00290	Genotyping Starter Kit, Cold Temperature	R03	02/04/03
	00450	SpectroTYPER™ autoflex^® System	R05	06/13/02
	00692	Control Pack, SNP Discovery Positive	R01	02/18/03
	00693	SNP Discovery Positive Control - Reverse	R01	11/20/02
	00694	SNP Discovery Positive Control - Forward	R01	11/20/02
	00695	SNP Discovery Starter Kit, Cold Temperature	R01	01/23/03
	00698	Starter Kit, SNP Discovery Room Temperature	R02	01/23/03
	01148	Allelotyping Starter Kit, Room Temperature	R01	04/24/03
	01149	Allelotyping Starter Kit, Cold Temperature	R01	04/24/03
	01250	System, MassARRAY™ Advanced	R00	06/07/02
	10003	OEM Purification Kit	R01	02/20/03
	10005	Allelotyping Starter Kit	R01	04/04/03
	10019	Allelotyping Software/Manuals	R00	06/20/03
	10021	Allelotyping w/High Throughput Upgrade	R00	01/27/03
	10022	Allelotyping w/o High Throughput Upgrade	R00	01/27/03
	10023	Allelotyping Positive Control, Pack	R01	04/24/03
	10024	MassARRAY™ Nanodispenser HT	R02	02/07/03
	10025	4X hME Starter Kit	R00	09/16/02
	10026	MassARRAY™ Nanodispenser LT	R01	02/07/03
	10027	Starter Kit, SNP Discovery	R01	02/04/03
	10028-001	MassARRAY™ Sample Tracking Nanodispenser (R), 110V	R00	09/18/03
	10028-002	MassARRAY™ Sample Tracking Nanodispenser (R), 230V	R00	09/18/03
	10029	MassARRAY™ Sample Tracking Linkstation	R00	09/18/03
	10030	hME Starter Kit	R08	03/01/02
	10051	MassEXTEND™ Tri-Mix Pack (1.2 mL)	R04	12/14/02
	10063	Kit, RNase Cleavage	R00	01/23/03
	10064	Kit, Transcription Reaction	R01	05/16/03
	10065	MassARRAY™ Nanodispenser S Upgrade Kit	R00	07/25/03
	10067-001	MassARRAY™ Sample Tracking System (R) 110V	R00	09/18/03
	10067-002	MassARRAY™ Sample Tracking System (R) 230V	R00	09/18/03
	10067-003	MassARRAY™ Sample Tracking System (S) 110V	R00	09/18/03
	10067-004	MassARRAY™ Sample Tracking System (S) 230V	R00	09/18/03
	10071	MassARRAY™ Sample Tracking Nanodispenser (S)	R00	09/18/03
	10540	MassARRAY™ System hME 120V	R06	06/13/02
	10550	SpectroCHECK™ Jet System 110V	R06	06/13/02
	10570	SpectroCHECK™ Point System 120V	R06	06/13/02
	10571	SpectroCHECK™ Point System 240V	R06	06/13/02
	10580	MassARRAY™ Point System 120V	R06	03/13/02
	10590	MassARRAY™ Point System 240V	R05	03/13/02
	10591-001	MassARRAY™ Sample Tracking Liquid Handler, 110V	R00	09/18/03
	10591-002	MassARRAY™ Sample Tracking Liquid Handler, 230V	R00	09/18/03
	10601	SpectroCHECK™ Jet System autoflex^® 110V	R01	06/13/02
	10602	MassARRAY™ OligoCHECK 7K System autoflex^® 120V	R02	01/29/03
	10603	MassARRAY™ OligoCHECK 7K System autoflex^® 240V	R02	01/29/03
	10604	MassARRAY™ System hME autoflex^® 120V	R01	06/26/02
	10605	MassARRAY™ 7k autoflex^® 120V	R01	06/26/02
	10606	MassARRAY™ 7K autoflex^® 240V	R01	06/26/02
	10607	MassARRAY™ Nanodispenser LT System 120v	R00	12/17/02
	10608	MassARRAY™ Nanodispenser HT System 120v	R00	12/17/02
	10609	MassARRAY™ Nanodispenser LT System 240v	R00	12/17/02
	10610	MassARRAY™ Nanodispenser HT System 240v	R00	12/17/02
	11150	MassARRAY™ Nanodispenser, 120V	R05	06/25/02
	11151	MassARRAY™ Nanodispenser, 240V	R05	06/25/02
	11153	MassARRAY™ Nanodispenser, 120V w/Low Volume Pin Set	R01	06/25/02
	11154	MassARRAY™ Nanodispenser, 240V w/Low Volume Pin Set	R01	06/25/02
	11155	MassARRAY™ Nanodispenser, 120V w/Low Volume Pin Set, CSA Approved	R01	08/22/02
	11160	MassARRAY™ Piezodispenser 96	R05	05/22/03
	11170	MassARRAY™ Piezodispenser 384	R08	05/21/03
	11175	MassARRAY™ Piezodispenser 384 hME	R08	05/21/03
	11200	MassARRAY™ Liquid Handler 96 System	R04	05/21/03
	11220	Clean Resin Kit	R08	10/04/02
	11226	SpectroCLEAN™ Resin Dispenser Assembly (Top Assembly)	R05	06/04/03
	11228	MassARRAY™ 384 Channel Liquid Handler hME	R01	10/04/02
	11230	MassARRAY™ Liquid Handler hME	R10	05/21/03
	11231	MassARRAY™ Liquid Handler hME 240V	R05	05/21/03
	11233	MassARRAY™ Liquid Handler High Throughput Upgrade	R07	08/01/03
	11234	Allelotyping MassARRAY™ Liquid Handler High Throughput Upgrade	R02	08/01/03
	11236	Kit, hMC Clean Resin	R01	12/10/02
	11302	RT Workstation, Biflex™ 110V	R12	09/02/03
	11303	Server, MassARRAY™	R15	06/19/03
	11304	RT Workstation, Biflex™ 230V	R09	09/02/03
	11305	Server, MassARRAY™, 230V	R14	06/19/03
	11306	RT Workstation, MassARRAY™ 110V	R07	06/19/03
	11307	RT Workstation, MassARRAY™ 230V	R07	06/19/03
	11313	Workstation, SpectroTYPER™ RT v2.0 110V or 230V FR	R02	05/21/02
	11314	Server, Replacement	R02	04/15/03
	11315	SpectroPOINT™ Low Volume	R00	02/12/02
	11316	MassARRAY™ Nanodispenser Low Volume, CSA Approved	R00	08/08/02
	11321	Workstation, Replacement RT (Dell)	R01	06/19/03
	60-00195	Voyager Mass Spec Assembly	R01	08/07/01
	60-10049	hME MassEXTEND™ Uni-Mix Pack	R02	08/07/01
	60-10050	hME MassEXTEND™ Di-Mix Pack	R02	08/07/01
	60-11152	SpectroJET™ Upgrade Kit	R00	10/03/01
	60-11205	384 Upgrade Kit	R03	08/07/01
	60-11210	SpectroPREP™ sME 384	R05	08/07/01
	*Miscellaneous*
	LIMS
	10/05/00	SEQUENOM LIMS Implementation Requirements Analysis
	1006-001	Module Design M020-20-02B (request hard copy from QA)
	1006-002	M020-30-02 Population Grouping	R01	10/28/00
	1006-003	M020-30-03 Rack Filling Module	R17	10/29/01
	1006-005	M020-30-05 Re-Arraying of Racks Module	R09	03/27/01
	1006-006	Module Design M020-30-21 (request hard copy from QA)
	1006-007	Lab Systems Nautilus Extension Documentation In-House Customizations (request hard copy from QA)
	1006-021	M020-30-21 Sample Naming Module	R02	12/13/00
	1006-022	M020-30-22 Assay Definition Tables	R05	06/16/01
	1006-026	M020-30-26 SpectroCALLER™ Report R11	R11	10/30/01
	1057-006	384 Well Plate QC for LIMS	R00	04/04/02
	1057-008	LIMS DNA Pooling Training Guide v1.0	R01	08/06/03
	1057-009	LIMS Fluoroskan File Converter Training Guide	R00	03/25/03
	1057-010	Initiating Plates into LIMS Plans Training Guide	R00	03/25/03
	1057-011	LIMS Stock Oligo Dilution Training Guide	R04	08/13/03
	1057-012	LIMS Plan Module 2.0 Training Guide	R02	06/24/03
	1057-013	MassARRAY™ 200K LIMS Interface Training Guide	R00	04/07/03
	Reports
	8720-001	Pathogen Identification, Reports and Meeting Minutes	R00	07/30/03
	8720-002	Pathogen Identification, Software Definition	R00	07/31/03
	Release Notes
	1056-001	SpectroTYPER™ v1.4.4 Release Notes	R01	05/09/01
	1056-003	MassARRAY™ Assay Design Version 1.3.4, MassARRAY™ IMPORTER Version 1.0 Release Notes	R02	02/11/03
	1056-004	MassARRAY™ Genotype Analyzer v1.4.5 Release Notes	R04	09/23/02
	1056-005	MassARRAY™ RT Software v3.0.1 Release Notes	R05	11/20/02
	1056-006	SpectroJET™ v1.06b Release Notes	R01	05/10/01
	1056-007	MassARRAY ™ RT v2.0 Service Pack r2.0 Release Notes	R02	10/31/02
	1056-009	MassARRAY™ Sample Tracking v1.1.1 Release Notes	R02	06/19/03
	1056-011	MassARRAY™ System Manufacture v3.0.1 Release Notes	R00	01/22/03
	1056-018	MassARRAY™ RT v2.0 Calling Changes for Multiplex Release Notes	R00	04/16/03
	2056-001	Multimek Install Disk, hME Standards, PN 11411 Software Change, 05/23/02	R00	06/19/02
	2056-002	Multimek Install Disk, hME High Throughput (HTP), PN 11425 Software Change, 05/23/02	R00	06/19/02
	2056-003	Dual Network Card Setup for MassARRAY™ RT Workstation Technical Bulletin, 09/02/03	R01	09/02/03
	2056-004	Troubleshooting Oracle Network Connections, 02/11/03	R00	02/11/03
	2056-005	Multimek Install Disk, hMC SNP DISCOVERY, PN 11433 Liquid Handler SNP Discovery Macros v2.0.2, 02/04/03	R00	02/10/03
	2056-006	MassARRAY™ OligoCHECK v3.0.4 Release Notes	R05	00/11/03
	2056-007	MassARRAY™ Assay Design v2.0.4 Release Notes	R01	03/26/03
	2056-008	Registering OCX Files	R00	02/27/03
	2056-009	Weekly NaOH Pin Cleaning Procedure for Nanodispenser (Samsung) Release Notes	R00	03/26/03
	2056-010	MassARRAY™ Nanodispenser Software Upgrade 2.0.7 Release Notes	R00	04/01/03
	2056-011	MassARRAY™ RT v3.0.1 "Patch" Release Notes	R00	04/10/03
	2056-012	Oracle 8i Client Install (all platforms), 8.1.7 Release Notes	R01	06/19/03
	2056-013	MassARRAY™ Typer v3.0.1 Service Pack 2 Release Notes	R00	04/24/03
	2056-014	MassARRAY™ SNP Discovery RT v1.2.2 Release Notes	R00	05/07/03
	2056-015	SpectroTYPER™ v2.0 Patch "A" Release Notes	R00	06/03/03
	E2056-016	MassARRAY™ RT Workstation v3.2.1 Release Notes (Engineering Released)	RX2	08/13/03
	E2056-017	MassARRAY™ Services v1.3.1 Release Notes (Engineering Released)	RX2	08/13/03
	2056-018	HT Nanodispenser Hotel Stacker Priming Protocol Technical Bulletin, 07/29/03	R00	07/29/03
	E2056-019	MassARRAY™ Typer 3.1.1 Release Notes (Engineering Released)	RX1	08/01/03
	E2056-020	MassARRAY™ Typer v3.1 Schema Changes Alpha Test Technical Bulletin, 08/01/03 (Engineering Released)	RX1	08/01/03
	2056-021	MassARRAY™ Assay Design v2.0.5 Release Notes	R00	08/25/03
	2056-022	Troubleshooting Oracle Network Connections Technical Bulletin, 09/02/03	R00	09/02/03
	2056-023	MassARRAY™ Services Logic Diagram Technical Bulletin, 09/02/03	R00	09/02/03
	2056-024	MassARRAY™ Services v1.2.2 Release Notes	R01	09/11/03
	2056-025	MassARRAY™ RT Workstation v3.0.4 Release Notes	R00	09/02/03
	Software Finished Goods
	1060-002	MassARRAY™ Typer Genotype Calling Criteria for Version 3.0	R00	03/24/03
	1060-003	MassARRAY™ Services Logic Diagram Technical Bulletin	R00	04/22/03
	Functional Specifications
	1057-001	Functional Specification for SpectroCHECK™	R01	02/02/01
	1057-002	Functional Specification for SpectroDESIGNER™	R00	02/02/01
	1057-003	Software Functional Specification for SpectroIMPORTER™	R00	04/12/01
	1058-001	SpectroDESIGNER™ Performance Testing	R00	02/02/01
	7057-001	Design Verification Procedure for Typer v3.1 Assay Editor Checklist Check-001	R00	08/08/03
	7057-002	Design Verification Procedure for Typer v3.1 Plate Editor Checklist Check-002	R00	08/08/03
	7057-003	Design Verification Procedure for Typer v3.1 Traffic Lights Checklist Check-003	R00	08/08/03
	7057-004	Design Validation Procedure for Typer v3.1 Assay Editor Checklist Check-001	R00	09/26/03
	7057-005	Design Validation Procedure for Typer v3.1 Plate Editor Checklist Check-002	R00	09/26/03
	7057-006	Design Validation Procedure for Typer v3.1 Typer Analyzer Checklist Check-003	R00	09/26/03
	7057-007	Design Validation Procedure for Services v2.0 Checklist Check-001	R00	09/26/03
	8057-001	Primer Extension on Dendrimeric Amine Silicon Surface Immobilized Primers	R00	02/28/02
	8557-001	SEQUENOM, Inc. Thermocycler Temperature Specifications	R00	03/06/03
	8857-004	Performance Evaluation: Use of the Tecan genesis to Prepare PCR Plates	R00	11/05/02
	8857-005	Software Functional Specification for Flow Cell Cycler v2.4	R02	03/26/03
	Labels
	2007-001	Label, Pre-Qualified	R02	05/18/01
	2007-002	Non-Conforming Material Tag	R00	03/25/02
	5007-001	Label, Approved	R01	04/20/01
	5007-002	Label, Quarantine	R01	04/20/01
	5007-003	Label, Reject	R01	04/20/01
	5007-004	Label, Rework	R01	04/20/01
	5007-005	Label, WIP	R01	04/20/01
	5007-007	Label, Partial Count	R01	11/20/01
	Engineering Specifications
	6085-001	SpectroCHIP™ - First Article Test	R07	04/28/03
	6522-001	Cartesian PixSys User Specification, 4200	R00	11/01/01
	Assays
	18701-000	Assay Design (18701-000 through 18701-022)	R00	05/22/02
	(Please contact Quality Assurance (QA) for electronic and/or hard copy.)
	18701-001	CFTR (Cystic Fibrosis Transmembrane Regulator) 3 MassEXTEND™ Primer hME Assay Design	R00	06/20/02
	18701-002	ACE-I/D (Angiotensin-converting Enzyme - Insertion/Deletion) hME Assay Design	R00	06/20/02
	18701-003	HPA1 (GPIIIa) hME Assay Design	R00	06/20/02
	18701-004	PAI1 hME Assay Design	R00	06/20/02
	18701-005	Angiotensin I (AGT) - M235T Mutation hME Assay Design	R00	06/20/02
	18701-006	Hemochromatosis (HFE) - H63D and C282Y Mutations hME Biplex Assay Design	R01	05/22/02
	18701-007	FV (F5) R506Q Mutation (FV Leiden)	R00	06/20/02
	18701-008	F7-R353Q mutation hME™ Uniplex Assay Design	R00	06/20/02
	18701-009	Fibrinogen (FGB) -455 (G/A) Mutation hME™ Assay Design	R00	06/20/02
	18701-010	CFTR (Cystic Fibrosis Transmembrane Regulator) ACMG Full Panel hME™ Assay Design 1.0 Manually Designed	R01	05/22/02
	18701-011	CCR5-32 mutation hME™ Uniplex Assay Design	R00	06/20/02
	18701-012	Canavan Disease - Y231X, E285A, and A305E mutations hME™ Triplex Assay Design	R00	06/20/02
	18701-013	Niemann-Pick Disease - R496L, L302P, and fsP330, mutations hME™ Triplex Assay Design	R00	06/20/02
	18701-014	HBB- codon 5,6 & 26 mutations hME™ Biplex Assay Design	R00	06/20/02
	18701-015	Mucolipidosis Type IV del6.4kb and 5534a>g, mutations hME™ Biplex Assay Design	R00	06/20/02
	18701-016	Alpha-1 Antitrypsin (AAT) - E342K and E264V Mutations hME™ Biplex Assay Design	R00	06/20/02
	18701-017	Gaucher Disease L444P, IVS2+1g>a, N370S, 84g>gg, and R496H, mutations hME™ 3-Biplex Assay Design	R00	06/20/02
	18701-018	Familial Dysautonomia, 76835a>g mutation hME™ Uniplex Assay Design	R00	06/20/02
	18701-019	Fanconi Anemia, IVS4+4a>t mutation, and Bloom Syndrome BLM^Ash mutation hME™ Biplex Assay Design	R00	06/20/02
	18701-020	APOAV (ApolipoproteinAV) hME™ Assay Design 1.0 SpectroDESIGNER™	R00	06/20/02
	18701-021	Factor II hME™ Assay Design	R00	06/20/02
	18701-022	Cystic Fibrosis G542X, N1303K, 508delF, W1282X, and 3849+10Kb c>t, mutations hME™ 3- Biplex Assay Design	R00	06/20/02
	18701-023	Tay-Sachs Disease 1278insTATC, IVS12+G>C, and G269S, mutations hME™ Triplex Assay Design	R00	06/20/02
	18701-024	Connexin26 Deletions in Hereditary Deafness 35delG, and 167delT, mutations hME™ Biplex Assay Design	R00	06/20/02
	18701-025	AMG (Amelogenin Sex Identification Test) hME™ Assay Design	R00	06/20/02
	Protocols
	P01015	Cartesian PixSys 4200 - Installation & Operation Qualification	R00	09/10/01
	P01016	PixSys Dispenser 4200 - IQ/OQ Final Report	R01	11/12/01
	P01017	Cartesian PixSys 4200, SN AD2333 - Performance Qualification	R00	11/09/01
	P01019-01	Automated Matrix Inspection PQ Addendum, 96+5 Configuration SpectroCHIP™ Products	R00	12/13/01
	P01019-02	RoboDesign Inspector, 2-D Matrix Decoding Software Upgrade (see QS for paper copy)	R01	01/13/03
	P01020	Automated Matrix Inspection PQ Addendum, 96+5 Configuration SpectroCHIP Products	R00	04/01/02
	P026002	Experimental Protocol for Testing Label and Print Ribbon Quality on Vials	R00	06/20/02
	P026002-1	Experimental Protocol for Testing Label and Print Ribbon Quality on Vials	R00	07/12/02
	P026003	Experimental Protocol for Establishing SpectroCHIP™ Shelf Life in Foil Pouch with Label, Clamshell and Desiccant	R00	06/20/02
	P026004	Cartesian PixSys 4200, 96+5 Program Qualification	R00	11/19/02
	P026005	MassARRAY™ 20K SEQ-006-67416-MO1 Installation/Operational/Performance Qualification	R00	12/13/02
	Validations
	EV01002	Heat Seal Study 384 Plates Verification/Validation (Engineering Release)	RX1	12/14/01
	V02600001	CentriVap ^® DNA System Model 79700-00 IQ/OQ Protocol	R00	02/20/02
	V026001	CentriVap ^® DNA System Model 79700-00 Process Qualification Protocol No. 026001	R00	03/12/02
	V026001-001	CentriVap ^® DNA System Model 79700-00 IQ/OQ Final Report Protocol No. 026001-001	R00	03/18/02
	V025902	Resin Stability Shelf Life Verification/Validation	R00	05/08/02
	EV025903	Plating Process 384 Plates Verification/Validation (Engineering Release)	RX1	04/26/02
	V025905	MassARRAY™ TRACKER Validation Plan Version 2.0	R00	08/20/02
	V025908	Gas Phase Silation Process Development and Validation Plan	R01	03/10/03
	V025911	Spectrophotometer Agilent 8453 Installation Qualification	R00	03/19/03
	V025912	Roselle Facility Process Validation	R00	11/05/02
	V025914	Guideline: SNP-Discovery Installation and Instrument Qualification	R00	02/26/03
	EV025914	Guideline: SNP-Discovery-RT Installation and Instrument Qualification (Engineering Released)	R01X2	07/03/03
	V035901	SNP Discovery Cleavage Mix Assay	R00	02/06/03
	V035902	SNP Discovery Calibrant HPLC Method	R00	02/06/03
	V035903	Biological and Functional Test of Biorad Resin Lot 78436A and 78481B Verification/Validation	R00	03/12/03
	V035904	Heat Seal Study 384 Plates Verification/Validation	R00	03/12/03
	V035905	Experimental Protocol for Qualifying the Use of Roche Raw Materials in the Manufacturing of` Sequenom's Extend Mixes	R00	04/03/03
	V035906	MassARRAY™ Assay Design Version 2.0 Final Verification Plan Retrospective Effort	R00	06/25/03
	V035909	SAMSUNG SpectroCHIP™ First Article Test Report	R00	08/13/03
	EV035910	Guideline: MassARRAY™ Typer Beta Test Installation (Engineering Released)	RX3	09/23/03
	V035912	Evaluation of OligoCHECK v3.0.4	R00	09/23/03