MENU PRODUCT MOLECULAR. International Product Listing. Simplexa Molecular Kits Integrated Cycler Molecular Reagents and Primer Pairs

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1 International Product Listing MOLECULAR PRODUCT MENU Simplexa Molecular Kits Integrated Cycler Molecular Reagents and Primer Pairs Products are not intended for donor screening.

2 Simplexa Molecular Kits Simplexa molecular kits are the culmination of Focus Diagnostics years of expertise in product development, providing your laboratory with the tools you need to bring molecular testing closer to your patients. THE UNIVERSAL DISC (96 wells) Simplexa Universal Direct Kits & Simplexa Kits Universal Direct no extraction required Run user-defined assays Process multiple targets simultaneously Higher volume testing Results in about an hour THE DIRECT AMPLIFICATION DISC (8 wells) Direct Amplification Discs are provided with kit Simplexa Direct kits - no extraction required Convenience of running 1 to 8 samples at a time Easy to understand results Elimination of unidirectional work flow All-in-one reaction mix packaged in single use vials Results in about an hour THE INTEGRATED CYCLER IS: Scalable, flexible, small and fast Easily integrated into a lab s daily operations 31cm deep; 21cm wide; 31cm high 110V/220V compatible - 2 -

3 Integrated Cycler Instrument and Consumables PRODUCT # DESCRIPTION QUANTITY MOL1011 CE FDA Integrated Cycler 1 220V laptop computer, accessories box, and optional printer MOL1001 CE FDA Integrated Cycler 1 110V laptop computer, accessories box, and optional printer MOL1400 CE FDA Universal Discs Case 100 MOL1401 CE FDA Universal Discs Box 25 MOL1500 CE FDA Universal Disc Cover Tape 250 MOL1451 CE FDA Direct Amplification Disc (DAD) 24 MOL1550 CE FDA Replacement Foil Wedges for DAD 48 Simplexa Direct Kits * for use on Direct Amplification Disc PRODUCT # PRODUCT NAME REACTIONS/KIT MOL2650 CE FDA Simplexa Flu A/B & RSV Direct Kit 24 A real-time RT-PCR assay for the in vitro qualitative detection and discrimination of influenza A, influenza B, and respiratory syncytial virus (RSV). Does not require extraction. MOL2150 CE FDA Simplexa HSV 1 & 2 Direct Kit 24 A real-time PCR assay for the in vitro qualitative detection and discrimination of HSV-1 and HSV-2 in cerebrospinal fluid (CSF) from patients with signs and symptoms of HSV infection of the central nervous system (CNS) or genitalia. Does not require extraction. MOL2850 CE FDA Simplexa Group A Strep Direct Kit 24 A real-time PCR assay for the in vitro qualitative detection of Group A Strep bacterial DNA. Does not require extraction. * Direct Amplification Discs are included with kit. Simplexa Universal Direct Kits for direct amplification on Universal Disc PRODUCT # PRODUCT NAME REACTIONS/KIT MOL2975 CE FDA Simplexa C. difficile Universal Direct Kit 100 A real-time PCR assay for the in vitro qualitative direct detection of the toxin B gene (tcdb) of C. difficile. Does not require extraction. MOL2700 CE Simplexa Bordetella Universal Direct Kit 100 A real-time PCR assay for the in vitro qualitative direct detection and discrimination of Bordetella pertussis and Bordetella parapertussis. Does not require extraction. MOL2775 CE Simplexa Bordetella Universal Direct Kit 1000 A real-time PCR assay for the in vitro qualitative direct detection and discrimination of Bordetella pertussis and Bordetella parapertussis. Does not require extraction. This higher volume version of the MOL2700 kit contains sufficient reagents to perform 1000 reactions directly from the specimen

4 Simplexa Kits for use on Universal Disc PRODUCT # PRODUCT NAME REACTIONS/KIT MOL2300 CE Simplexa BKV Kit 100 A real-time PCR assay for the in vitro quantitation of BK Virus (BKV). MOL2200 CE Simplexa CMV Kit A real-time PCR assay for the in vitro quantitation of cytomegalovirus (CMV). MOL3100 CE Simplexa Dengue Kit 100 A real-time PCR assay for the in vitro detection and typing of dengue virus serotypes 1, 2, 3, and 4. MOL2400 CE Simplexa EBV Kit 100 A real-time PCR assay for the in vitro quantitation of Epstein-Barr virus (EBV). MOL2600 CE FDA Simplexa Flu A/B & RSV Kit 100 A real-time RT-PCR assay for the in vitro qualitative detection and discrimination of influenza A, influenza B, and respiratory syncytial virus (RSV). MOL2500 CE FDA Simplexa Influenza A H1N1 (2009) Kit 100 A real-time RT-PCR assay for the in vitro qualitative detection and differentiation of seasonal influenza A and 2009 H1N1 influenza. Simplexa Quantitation Standards PRODUCT # PRODUCT NAME VOLUME MOL2310 CE Simplexa BKV Quantitation Standards 5 x 400μL Intended to establish a standard curve with the Simplexa BKV assay. Includes 5 vials; each vial contains 400μL. MOL2210 CE Simplexa CMV Quantitation Standards 5 x 400μL 0344 Intended to establish a standard curve with the Simplexa CMV assay. Includes 5 vials; each vial contains 400μL. MOL2410 CE Simplexa EBV Quantitation Standards 5 x 400μL Intended to establish a standard curve with the Simplexa EBV assay. Includes 5 vials; each vial contains 400μL. Simplexa Process Control Sets PRODUCT # PRODUCT NAME REACTIONS/KIT MOL9000 CE FDA Simplexa Extraction and Amplification Control Set 100 This set consists of a DNA template and labeled primer pair intended to be used as a process control to detect systemic variation that may arise during the extraction and amplification steps of real-time PCR assays. MOL9300 CE FDA Simplexa Extraction and Amplification Control Set 1000 This is a larger volume set of MOL9000. MOL9200 CE FDA Simplexa Extraction and Amplification Control Set RNA 100 This set consists of a RNA template and labeled primer pair intended to be used as a process control to detect systemic variation that may arise during the extraction and amplification steps of real-time RT-PCR assays

5 Simplexa Controls PRODUCT # PRODUCT NAME VOLUME MOL8011 FDA Simplexa Adenovirus Molecular Control 2 x 250μL Inactivated adenovirus in human base matrix. MOL8009 FDA Simplexa BKV Molecular Control 2 x 250μL DNA fragment of a well conserved region of BKV VP2 gene in human base matrix. MOL8006 FDA Simplexa Bordetella Molecular Control 2 x 50μL DNA fragment containing both the IS481 and IS1001 target regions. MOL8002 FDA Simplexa CMV Molecular Control 2 x 250μL DNA fragment containing a well conserved region of CMV UL83 gene in human base matrix. MOL3103C FDA Simplexa Dengue Molecular Control 2 x 800μL Inactivated dengue virus including serotypes 1, 2, 3 and 4. MOL8008 FDA Simplexa EBV Molecular Control 2 x 250μL DNA fragment of a well conserved region of EBV LMP2A gene in human base matrix. MOL8033 FDA Simplexa Group A Streptococcus Molecular Control 2 x 250μL Inactivated Group A Streptococcus bacteria. MOL2860 Simplexa Group A Streptococcus Positive Control Pack 10 x 100μL Inactivated Group A Streptococcus bacteria. MOL2660 CE FDA Simplexa Flu A/B & RSV Positive Control Pack Inactivated influenza A virus, inactivated influenza B virus, and inactivated RSV intended to be used as a control in molecular testing. Includes 10 controls per pack. MOL2160 CE FDA Simplexa HSV 1 & 2 Positive Control Pack Inactivated HSV 1 and 2 virus intended to be used as a control with the Simplexa HSV 1 & 2 Direct kit. Includes 10 controls per pack. Molecular Reagents PRODUCT # PRODUCT NAME VOLUME MOL X Universal Master Mix 2 x 200μL Developed for low volume applications and supplied in a 2.5X concentration solution. Sufficient for 100 reactions. Contains all of the necessary PCR components (enzyme, dntps, buffer, MgCl 2 ). MOL X Universal Master Mix 1 x 860μL This is a larger volume configuration of MOL9010. Sufficient for 215 reactions. MOL9060G HS Master Mix 4 x 200μL Developed for use with primer pairs requiring a high salt master mix. Sufficient for 200 reactions. Contains the necessary PCR components (enzyme, dntps, buffer, MgCl 2 ). MOL9070 Temperature Activated Enzyme Master Mix 2 x 200μL Enzyme activity is blocked until heat activated during the initial PCR step. Sufficient for 100 reactions. Contains the necessary PCR components (enzyme, dntps, buffer, MgCl 2 ). MOL9370 Temperature Activated Enzyme Master Mix 1 x 440μL This is a larger volume configuration of MOL9070. Sufficient for 110 reactions. MOL9018 Reverse Transcriptase Enzyme 1 x 50μL Buffered enzyme to transcribe RNA templates into cdna. Sufficient for 100 reactions

6 Primer Pairs - Genetics MOL9052 Factor II (Prothrombin) Mutant G20210A Q µL MOL9053 Factor II (Prothrombin) Wild Type G20210WT JOE (560) 50µL MOL9050 Factor V Leiden Mutant G1691A CFR µL MOL9051 Factor V Wild Type G1691WT FAM (520) 50µL MOL9054 MTHFR 677 Mutant C677T CFR µL MOL9055 MTHFR 677 Wild Type Nucleotide 677 FAM (520) 50µL MOL9056 MTHFR 1298 Mutant A1298C Q µL MOL9057 MTHFR 1298 Wild Type Nucleotide 1298 JOE (560) 50µL Primer Pairs - Healthcare Associated Infections MOL9026 C. difficile Toxin B FAM (520) 50µL MOL9035 KPC bla KPC FAM (520) 50µL MOL9027 Norovirus I ORF1/ORF2 CFR µL MOL9028 Norovirus II ORF1/ORF2 FAM (520) 50µL Primer Pairs - Infectious Diseases MOL9015 Borrelia Flagellin FAM (520) 50µL MOL9039 Chikungunya Alphavirus E-1 Glycoprotein FAM (520) 50µL MOL9041 Dengue Virus 1 NS5 FAM (520) 50µL MOL9042 Dengue Virus 2 NS5 CFR µL MOL9043 Dengue Virus 3 NS3 FAM (520) 50µL MOL9044 Dengue Virus 4 Capsid CFR µL MOL9020 Enterovirus 5 Non-Coding Region FAM (520) 50µL MOL9037 HSV-1 Gen II HSV-1 Polymerase CFR µL MOL9004 HSV-2 HSV-2 Polymerase FAM (520) 50µL MOL9038 Parechovirus 5 Untranslated Region CFR µL MOL9019 Parvovirus VP1 FAM (520) 50µL MOL9025 T. gondii B1 FAM (520) 50µL - 6 -

7 Primer Pairs Immunocompromised MOL9011 Adenovirus 3 Hexon 3 Hexon Polypeptide FAM (520) 50µL MOL9012 Adenovirus 5 Hexon 5 Hexon Polypeptide FAM (520) 50µL MOL9009 BKV VP2 FAM (520) 50µL MOL9002 CMV UL83 FAM (520) 50µL MOL9008 EBV LMP2A FAM (520) 50µL MOL9022 HHV-6 P100 FAM (520) 50µL MOL9021 JCV VP2/3 CFR µL MOL9024 VZV DNA Polymerase JOE (560) 50µL Primer Pairs Respiratory MOL9036 B. holmesii his1001 Insertion JOE (560) 50µL MOL9007 B. parapertussis IS1001 Insertion CFR µL MOL9006 B. pertussis IS481 Insertion FAM (520) 50µL MOL9023 C. pneumoniae Cpn0980 FAM (520) 50µL MOL9033 Group A Strep Exotoxin B FAM (520) 50µL MOL9029 hmpv F gene FAM (520) 50µL MOL9016 Influenza A Matrix FAM (520) 50µL MOL9017 Influenza B Matrix JOE (560) 50µL MOL9034 L. pneumophila pmia CFR µL MOL9013 M. pneumoniae P1 FAM (520) 50µL MOL9030 Parainfluenza 1 HN FAM (520) 50µL MOL9031 Parainfluenza 2 HN JOE (560) 50µL MOL9032 Parainfluenza 3 HN CFR µL MOL9014 RSV Matrix CFR µL Primer Pairs High Volume MOL9307 B. parapertussis IS1001 Insertion CFR μL MOL9306 B. pertussis IS481 Insertion FAM (520) 200μL MOL9304 HSV-2 HSV-2 Polymerase FAM (520) 200μL MOL9337 HSV-1 Gen II HSV-1 Polymerase CFR μL MOL9324 VZV DNA Polymerase JOE (560) 200μL - 7 -

8 Look for Soon Simplexa Kits and Controls PRODUCT # MOL2750 MOL2760 MOL2950 MOL2960 MOL3250 MOL3260 DESCRIPTION Simplexa Bordetella Direct Kit Simplexa Bordetella Positive Control Pack Simplexa C. difficile Direct Kit Simplexa C. difficile Positive Control Pack Simplexa Enterovirus and Parechovirus Direct Kit Simplexa Enterovirus and Parechovirus Positive Control Pack Look for Soon Primer Pairs PRODUCT # MOL9048 MOL9047 MOL9093 MOL9094 MOL9046 MOL9095 MOL9049 MOL9045 DESCRIPTION Chlamydia trachomatis Group B Strep Group C Strep Group G Strep MERS E-gene MERS M-gene Neisseria gonorrhoeae Pan Dengue For additional product information, contact Focus Diagnostics Customer Service DXCS@focusdx.com Phone: Fax: Focus Diagnostics products are available through your local distributor. To locate the distributor in your area, visit our Web site: YOUR BEST LAB. ALWAYS IN FOCUS. Cypress, California LITERATURE FOR DISTRIBUTION OUTSIDE USA ONLY Focus Diagnostics, the associated logo, Simplexa and the associated logo are all trademarks or registered trademarks of Focus Diagnostics. Focus Diagnostics, Inc All rights reserved. The use of Scorpions Probes for human in vitro diagnostic purposes is covered by a license to Focus Diagnostics, Inc. from DxS, Ltd. Black Hole Quencher, CAL Fluor, Quasar dyes are trademarks of Biosearch Technologies, Inc. ( BTI ). Black Hole Quencher, CAL Fluor and Quasar dye technology is licensed pursuant to an agreement with BTI, and these products are sold exclusively for clinical, diagnostic, or research and development purposes. DXMPMI0516