PBRs

Manufacturing Quality Assurance Finished Goods	Doc #	Document Description	Rev #	Effective Date	AIDs Artwork Assay Assembly Audit External Forms Labels Manuals MSDS NPC Obsoletes PBRs Protocols Release Notes Reports Specs SOPs Tech Bulletins Validations
	*Manufacturing*
	00007	1M Tris - HC1 pH 8.0	R04	03/27/02
	00015	1M Tris - HC1 pH 9.5	R03	03/27/02
	00040	3X Beads Binding / Washing Buffer	R06	04/09/02
	00041	1X Tris - EDTA	R05	03/27/02
	00042	500 mM Ammonium Hydroxide (NH₄OH)	R05	04/09/02
	00048	White Blood Cell Lysis Buffer	R02	07/14/00
	00051	Red Blood Cell Lysis Buffer	R02	07/14/00
	00055	Protein Precipitation Solution	R04	08/07/01
	00056	10M Sodium Hydroxide (NaOH)	R04	03/27/02
	00060	10X EXTEND Buffer	R03	03/27/02
	00063	50% Acetonitrile / Water Solution	R01	07/18/01
	00064	20X EXTEND Buffer	R03	03/27/02
	00087	100 mM Tris - HC1 pH 8.0	R05	09/13/00
	00088	1M Sodium Hydroxide (NaOH)	R04	03/27/02
	00137	500M Ammonium Acetate Solution	R02	05/07/02
	00150	96+5 SpectroCHIP™ in Clamshell	R14	03/20/03
	00150A	96+5 SpectroCHIP™ in Clamshell - Rework	R00	11/11/02
	00151	96+5 SpectroCHIP™ Packaging at Jorsow, Inc.	R08	09/16/02
	S00151	Empaquetado del SpectroCHIP™ 96+5 En Jorsow, Inc.	R08	09/17/02
	00151A	SpectroCHIP™, 96+5 Pads, Pouched - Rework	R07	04/01/02
	00152	384+10 SpectroCHIP™ in Clamshell	R17	01/10/03
	00152A	384+10 SpectroCHIP™ in Clamshell - Rework	R00	09/09/02
	00153	384+10 SpectroCHIP™ Packaging at Jorsow, Inc.	R11	09/09/02
	S00153	Empaquetado del SpectroCHIP™ 384+10 En Jorsow, Inc.	R11	09/09/02
	00153A	SpectroCHIP™, 384+10 Pads, Pouched - Rework	R08	06/18/02
	00181	Piranha Solution Preparation	R01	01/25/02
	00203	5 Pt Calibrant Liquid - hME	R00	02/12/01
	00205	300mM Matrix Solution	R05	04/03/02
	00335	3 Pt Calibrant, Liquid	R06	11/07/02
	00338	Wash & Conditioning Buffer	R04	06/04/02
	00340	Denaturation Solution	R07	06/04/02
	00341	Recovery Solution	R04	06/04/02
	00342	Bead, 96 Fill	R04	12/13/00
	00343	Binding Buffer	R05	06/04/02
	00423	4-Pt Calibrant, Liquid - hMC	R03	01/27/03
	00600	SpectroCHIP™ 96 Pad, 10-Pack	R06	06/03/03
	00601	SpectroCHIP™ 384 Pad, 10-Pack	R04	06/03/03
	00603	MassEXTEND™ 96 Reagent Set	R05	03/18/02
	00604	MassEXTEND™ 384 Reagent Set	R06	03/18/02
	00611	Bead, 384 Fill	R01	11/06/00
	00620	MassEXTEND™ Mix 1	R03	08/28/03
	00621	MassEXTEND™ Mix 2	R04	09/17/03
	00622	MassEXTEND™ Mix 3	R04	09/17/03
	00623	MassEXTEND™ Mix 4	R04	09/17/03
	00624	MassEXTEND™ Mix 5	R04	08/28/03
	00625	MassEXTEND™ Mix 6	R03	08/28/03
	00626	MassEXTEND™ Mix 7	R03	08/29/03
	00627	MassEXTEND™ Mix 8	R04	09/17/03
	00628	MassEXTEND™ Mix 9	R04	09/17/03
	00629	MassEXTEND™ Mix 10	R04	09/17/03
	00630	MassEXTEND™ Mix 11	R03	08/29/03
	00631	MassEXTEND™ Mix 12	R03	08/29/03
	00632	MassEXTEND™ Mix 13	R03	08/28/03
	00633	MassEXTEND™ Mix 14	R04	09/17/03
	00634	dNTP Mix, 25 mM	R04	06/18/02
	00636	SpectroCHIP™ A384, 8-Pack	R01	06/03/03
	00637	SpectroCHIP™ G384, 10 Pack	R01	06/03/03
	00688	SNP Discovery Reverse Positive Control Assay - Antisense Primer	R01	01/23/03
	00689	SNP Discovery Reverse Positive Control Assay - Sense Primer	R01	01/23/03
	00690	SNP Discovery Forward Positive Control Assay - Antisense Primer	R01	02/04/03
	00691	SNP Discovery Forward Positive Control Assay - Sense Primer	R01	02/04/03
	00778	40X Extend Buffer	R00	08/29/03
	01001	Metal Disk, Coded	R01	06/05/02
	01179	ACG Control F - Forward PCR Primer	R01	11/07/02
	01180	ACG Control R - Reverse PCR Primer	R01	11/07/02
	01181	ACG Control E - EXTEND Primer	R01	11/07/02
	01182	ACT Control F - Forward PCR Primer	R01	11/07/02
	01183	ACT Control R - Reverse PCR Primer	R01	11/07/02
	01184	ACT Control E - EXTEND Primer	R01	11/07/02
	01185	AGT Control F - Forward PCR Primer	R01	11/07/02
	01186	AGT Control R - Reverse PCR Primer	R01	11/07/02
	01187	AGT Control E - EXTEND Primer	R01	11/07/02
	01188	CGT Control F - Forward PCR Primer	R01	11/07/02
	01189	CGT Control R - Reverse PCR Primer	R01	11/07/02
	01190	CGT Control E - EXTEND Primer	R01	11/07/02
	01234	A384+10 SpectroCHIP™ in Clamshell	R01	03/20/03
	01234A	A384+10 SpectroCHIP^™ in Clamshell	R00	09/26/02
	01235	A384+10 SpectroCHIP^™ Packaging at Jorsow, Inc.	R01	12/09/02
	01252	G384+10 SpectroCHIP™ w/Data Matrix in Clamshell	R02	03/20/03
	01252A	G384+10 Genotyping SpectroCHIP™ w/Data Matrix in Clamshell - Rework	R00	11/12/02
	01254	G384+10 SpectroCHIP™ Packaging at Jorsow, Inc.	R01	12/10/02
	01280	T7 R&DNA Polymerase	R05	01/27/03
	01281	C Cleavage Transcription Mix	R04	01/27/03
	01283	T Cleavage Transcription Mix	R04	01/27/03
	10002	Shrimp Alkaline Phosphatase Enzyme	R04	11/07/02
	10006	ACG Control Assay	R01	11/07/02
	10007	ACT Control Assay	R01	11/07/02
	10008	AGT Control Assay	R01	11/07/02
	10009	CGT Control Assay	R01	11/07/02
	10010	MassEXTEND™ 96 Core Kit	R05	03/12/02
	10020	MassEXTEND™ 384 Core Kit	R04	01/23/01
	10032	5-Pt Calibrant, Dried - hME	R01	03/18/02
	10033	Positive Control MassEXTEND™ Template	R04	11/07/02
	10034	Positive Control MassEXTEND™ Primer	R05	11/07/02
	10035	MassEXTEND™ Mix 15 Uni	R05	08/28/02
	10036	MassEXTEND™ Mix 16 Uni	R06	09/17/03
	10037	MassEXTEND™ Mix 17 Uni	R06	09/17/03
	10038	MassEXTEND™ Mix 18 Uni	R06	09/17/03
	10039	MassEXTEND™ Mix 19 Di	R05	08/28/03
	10040	MassEXTEND™ Mix 20 Di	R05	08/28/03
	10041	MassEXTEND™ Mix 21 Di	R05	08/28/03
	10042	MassEXTEND™ Mix 22 Di	R06	09/17/03
	10043	MassEXTEND™ Mix 23 Di	R06	09/17/03
	10044	MassEXTEND™ Mix 24 Di	R06	09/17/03
	10045	MassEXTEND™ Mix 25 Tri (1.2 mL)	R07	08/28/03
	10046	MassEXTEND™ Mix 26 Tri (1.2 mL)	R07	08/28/03
	10047	MassEXTEND™ Mix 27 Tri (1.2 mL)	R07	08/28/03
	10048	MassEXTEND™ Mix 28 Tri (1.2 mL)	R09	09/17/03
	10052	Thermo Sequenase™ Enzyme	R02	11/07/02
	10053	Clean Resin (20 g)	R06	10/04/02
	10055	hME Buffer	R03	11/07/02
	10056	Scrapie, MassEXTEND Mix 29	R03	09/17/03
	10059	5X T7 R&DNA Polymerase Buffer	R03	01/22/03
	10060	RNase-Free Water	R02	01/23/03
	10061	Ribonuclease A	R02	01/22/03
	10062	DTT	R02	01/23/03
	10066	2M Tris-HC1, pH 9.5	R00	08/29/03
	10300	Positive Control Pack	R05	03/01/02
	10400	Nucleotide Uni-Mix Pack	R02	01/23/01
	10401	Nucleotide Di-Mix Pack	R02	01/23/01
	10402	Nucleotide Tri-Mix Pack	R02	01/23/01
	12002	GeSIM Pump, Silated 1536	R05	01/28/02
	*Quality Assurance*
	11400	SpectroTYPER™ Software v1.4.4	R02	02/21/01
	11404	MassARRAY™ OligoCHECK v1.3 Build 66	R07	12/11/02
	11405	MassARRAY™ DESIGNER v1.3.4 MassARRAY™ IMPORTER v1.0.1 CD	R10	02/11/03
	11406	MassARRAY™ Genotype Analyzer v1.4.5	R10	11/01/02
	11407	Oracle^® Developer 6	R02	06/02/01
	11408	Oracle^®8.0.5.0.0	R02	06/02/01
	11409	Oracle^®Installer	R03	06/02/01
	11411	Multimek Install Disk, hME Standards, rev 3.0	R03	06/25/02
	11412	MassARRAY™ RT Software v2.0	R11	10/29/02
	11414	SpectroJET™ v1.06b	R01	05/10/01
	11418	hME SpectroPREP™ (Resin Dispenser Macros) MM #2	R00	02/07/02
	11419	DNA Low Mass	R01	09/25/02
	11420	MassARRAY™ OligoCHECK v2.0.3	R01	02/21/03
	11421	MassARRAY™ RT v2.0 Service Pack r2.0	R03	10/31/02
	11422	MassARRAY™ RT v2.0 r1.0 (autoflex^®)	R05	09/30/03
	11423	Resin Dispenser Program Disc	R01	04/17/02
	11425	Multimek Install Disk, hME High Throughput (HTP)	R00	06/25/02
	11427	Allelotyping Methods and Macros	R00	09/18/02
	11428	NT Service Pack 6a	R00	09/30/02
	11430	Multimek Methods & Macros for MassARRAY™ Sample Tracking System, v1.0	R01	08/26/02
	11431	MassARRAY™ OligoCHECK Software Patch for v1.3.0.66	R00	08/07/02
	E11432	MassARRAY™ Sample Tracking v1.1.1	R03X1	06/25/03
	11433	Liquid Handler SNP Discovery Macros v2.0.2	R03	02/10/03
	11434	MassARRAY™ Discovery-RT Software v1.2.2	R02	05/07/03
	11435	Oracle^® 8.1.7 Release 3, Server Standard Edition	R00	10/10/02
	11436	Oracle^® 8.1.7 Release 3, Client	R01	04/24/03
	11437	MassARRAY™ RT Software v3.0.1	R01	11/01/02
	11438	MassARRAY™ System Manufacturing v3.0.1	R00	01/22/03
	11439	Oracle^® 8.1.7 ODBC Patch	R01	01/10/03
	11440	MassARRAY™ Assay Design v2.0.4	R00	03/24/03
	11441	CD, Oracle^® 8.1.7.4.1 Patch (Manufacturing Only)	R01	01/23/03
	11442	MassARRAY™ Typer v3.0.1, Service Pack 2	R01	04/24/03
	11443	MassARRAY™ Services v1.1.5 (Manufacturing Only)	R01	04/10/03
	E11443	MassARRAY™ Services v1.3.1 (Engineering Release)	R02X2	08/07/03
	11444	MassARRAY™ RT Software v2.0 Patch, with SpectroANALYZER v2.0.1.5	R00	02/21/03
	11445	MassARRAY™ RT Software v2.0 Patch, with SpectroWRITER v2.0.1.6	R00	02/21/03
	11446	MassARRAY™ OligoCHECK v3.0.4	R00	09/11/03
	11447	MassARRAY™ Nanodispenser S v2.0.7	R00	04/09/03
	11448	MassARRAY™ RT v2.0 Calling Changes for Multiplex	R01	04/25/03
	11449	Oracle^® Client 8.1.7 (All Platforms)	R00	04/24/03
	E11451	MassARRAY™ RT Workstation v3.2.1 (Engineering Released)	RX2	08/07/03
	11452	MassARRAY Assay Design v2.0.5	R00	08/25/03
	E11453	MassARRAY Typer v3.1.1 (Engineering Released)	RX1	08/07/03
	11454	MassARRAY™ RT Workstation v3.0.4	R00	09/11/03
	11455	MassARRAY™ Services v1.2.2	R00	09/11/03
	11502	SpectroTYPER™ v1.4.4 User's Guide	R01	05/29/01
	11503	SpectroREADER™ Biflex User's Guide	R01	05/07/01
	11504	SpectroREADER™ Voyager User's Guide	R01	03/13/01
	11505	MassARRAY™ Nanodispenser v1 r6 User's Guide	R05	09/12/03
	11506	MassARRAY™ Server System Administration Guide v1.4.5	R02	05/07/01
	11509	SpectroPREP™ Standard MassEXTEND™ (sME) ver 1 rev 2 User's Guide	R02	07/10/01
	11510	MassARRAY™ DESIGNER v1.3.4 / MassARRAY™ IMPORTER v1.0.1 User's Guide	R04	03/08/03
	11511	MassARRAY™ OligoCHECK RT User's Guides v2 r3	R06	02/05/03
	11512	SpectroTYPER™ v1.4.5 User's Guide	R01	03/13/01
	11513	SpectroTYPER™ RT v2.0 User's Guide (biflex)	R01	11/16/01
	11514	MassARRAY™ Server System Administration Guide v3.0	R01	11/27/02
	11515	SpectroJET™ v1.06b User's Guide	R00	05/04/01
	11519	SpectroCLEAN™ Resin Dispenser Homogeneous MassEXTEND™ (hME) v1 r00 User's Guide	R01	02/06/02
	11520	MassARRAY™ Typer v3.0 User's Guide (autoflex^®)	R02	09/20/02
	11521	MassARRAY™ Typer v3.0 User's Guide (biflex^®)	R00	09/20/02
	11522	MassARRAY™ Sample Tracking v1.1.1 User's Guide	R00	09/12/03
	11523	MassARRAY™ SNP Discovery User's Guides v1.2 r1	R02	04/25/03
	11525	MassARRAY™ Nanodispenser S User's Guide v1 r1	R02	04/10/03
	11526	MassARRAY™ OligoCHECK RT v3.0 r5 User's Guides (autoflex^® and biflex^®)	R01	09/12/03
	11527	MassARRAY™ Liquid Handler User's Guide (hME) v1 r8	R01	09/12/03
	E11527	MassARRAY™ Liquid Handler User's Guide (hME) v1 r10 (Engineering Release)	R02X1	09/22/03
	11528	MassARRAY™ Assay Design v2.0.5 r1 / MassARRAY™ Importer v3.0.7 r1 User's Guide	R02	09/12/03
	E11528	MassARRAY™ Assay Design v2.0.6 r1 / MassARRAY™ Importer v3.0.7 r1 User's Guide (Engineering Release)	R03X1	09/26/03
	E11529	MassARRAY™ RT Workstation CD v3.0.3 (Engineering Release)	RX1	06/17/03
	E11530	MassARRAY™ Typer User's Guide v3.1 r1 (autoflex^®) (Engineering Release)	RX2	09/24/03
	E11531	MassARRAY™ Typer User's Guide v3.1 r1 (biflex^®) (Engineering Release)	RX2	09/24/03
	Finished Goods
	18701-001	CFTR (Cystic Fibrosis Transmembrane Regulator) 3 MassEXTEND™ Primer hME Assay Design	R00	06/26/02
	18701-002	ACE-I/D (Angiotensin-converting Enzyme - Insertion/Deletion) hME Assay Design	R00	06/26/02
	18701-003	HPA1 (GPIIIa) hME Assay Design	R00	06/26/02
	18701-004	PAI1 hME Assay Design	R00	06/26/02
	18701-005	Angiotensin I (AGT) - M235T Mutation hME Assay Design	R00	06/26/02
	18701-006	Hemochromatosis (HFE) - H63D and C282Y Mutations hME Biplex Assay Design	R01	05/22/02
	18701-007	FV (F5) R506Q Mutation (FV Leiden) Assay Design	R00	06/26/02
	18701-008	F7-R353Q mutation hME™ Uniplex Assay Design	R00	06/26/02
	18701-009	Fibrinogen (FGB) -455 (G/A) Mutation hME™ Assay Design	R01	07/24/02
	18701-010	CFTR (Cystic Fibrosis Transmembrane Regulator) ACMG Full Panel hME™ Assay Design 1.0 Manually Designed	R02	10/08/02
	18701-011	CCR5-32 mutation hME™ Uniplex Assay Design	R00	06/26/02
	18701-012	Canavan Disease - Y231X, E285A, and A305E mutations hME™ Triplex Assay Design	R00	06/26/02
	18701-013	Niemann-Pick Disease - R496L, L302P, and fsP330, mutations hME™ Triplex Assay Design	R00	06/26/02
	18701-014	HBB- codon 5,6 & 26 mutations hME™ Biplex Assay Design	R00	06/26/02
	18701-015	Mucolipidosis Type IV del6.4kb and 5534a>g, mutations hME™ Biplex Assay Design	R00	06/26/02
	18701-016	Alpha-1 Antitrypsin (AAT) - E342K and E264V Mutations hME™ Biplex Assay Design	R00	06/26/02
	18701-017	Gaucher Disease L444P, IVS2+1g>a, N370S, 84g>gg, and R496H, mutations hME™ 3-Biplex Assay Design	R00	06/26/02
	18701-018	Familial Dysautonomia, 76835a>g mutation hME™ Uniplex Assay Design	R00	06/26/02
	18701-019	Fanconi Anemia, IVS4+4a>t mutation, and Bloom Syndrome BLM^Ash mutation hME™ Biplex Assay Design	R00	06/26/02
	18701-020	APOAV (ApolipoproteinAV) hME™ Assay Design	R01	08/08/02
	18701-021	Factor II hME™ Assay Design	R00	06/26/02
	18701-022	Cystic Fibrosis G542X, N1303K, 508delF, W1282X, and 3849+10Kb c>t, mutations hME™ 3- Biplex Assay Design	R00	06/26/02
	18701-023	Tay-Sachs Disease 1278insTATC, IVS12+G>C, and G269S, mutations hME™ Triplex Assay Design	R00	08/02/02
	18701-024	Connexin26 Deletions in Hereditary Deafness 35delG, and 167delT, mutations hME™ Biplex Assay Design	R00	08/02/02
	18701-025	AMG (Amelogenin Sex Identification Test) hME™ Assay Design	R00	08/02/02