Other products from "ROCHE MOLECULAR SYSTEMS, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00875197006254 08688214190 08688214190 QLX Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA 2 cobas&#x00AE EBV/BKV Control Kit
2 00875197005998 07948352190 07948352190 NPR,NPQ TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,TEST, FACTOR V LEIDEN MUTATIO TEST, FACTOR II G20210A MUTATIONS, GENOMIC DNA PCR,TEST, FACTOR V LEIDEN MUTATIONS, GENOMIC DNA PCR 2 cobas Factor II and Factor V Test
3 00875197005646 07402678190 07402678190 PGX Groups A, C And G Beta-Hemolytic Streptococcus Nucleic Acid Amplification System 2 cobas® Strep A Quality Control Kit for use on the cobas® Liat® System
4 00875197005363 2.0 07102577190 OOI,LSL,MKZ real time Nucleic acid amplification system,DNA-REAGENTS, NEISSERIA,DNA PROBE, N real time Nucleic acid amplification system,DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA 1 cobas® 4800 CT/NG Test v2.0
5 00875197005356 2.0 07102569190 LSL,MKZ,OOI DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,real ti DNA-REAGENTS, NEISSERIA,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,real time Nucleic acid amplification system 1 cobas® 4800 CT/NG Test v2.0
6 00875197004458 1.0 06768318190 OQO Herpes Simplex Virus Nucleic Acid Amplification Assay 2 cobas® 4800 Systems Internal Control Kit
7 00875197004427 1.0 06768172190 NQX,OOI SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCC SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN,real time Nucleic acid amplification system 2 cobas® MRSA/SA Test
8 00875197004410 1.0 06768113190 OOI,NQX real time Nucleic acid amplification system,SYSTEM, NUCLEIC ACID AMPLIFICATION T real time Nucleic acid amplification system,SYSTEM, NUCLEIC ACID AMPLIFICATION TEST, DNA, METHICILLIN RESISTANT STAPHYLOCOCCUS AUREUS, DIRECT SPECIMEN 2 cobas® MRSA/SA Test
9 00875197004120 05985536190 05985536190 OWD Somatic gene mutation detection system 3 cobas® DNA Sample Preparation Kit
10 00875197003215 1.0 05235847190 LSL,OOI,MKZ DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system,DNA PROBE, N DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system,DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA 1 cobas® 4800 System Control Diluent Kit
11 00875197003185 05235804190 05235804190 MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 cobas® 4800 System Sample Preparation Kit
12 00875197003178 05235782190 05235782190 MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 cobas® 4800 System Sample Preparation Kit
13 00875197001983 03568555190 03568555190 MZP ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS 2 COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test
14 00875197001068 2 03302563018 COBAS® AmpliScreen HCV Test, v2.0
15 00875197000993 2 03155935018 MTL MONITOR,TEST,HIV-1 3 COBAS AMPLICOR HIV-1 Monitor Test, version 1.5
16 08430215046203 03531414001 03531414001 OOI real time Nucleic acid amplification system 2 LightCycler® 2.0 Instrument
17 07613336171295 08988218001 08988218001 JQW STATION, PIPETTING AND DILUTING, FOR CLINICAL USE 1 cobas&#x00AE prime Secondary Tube Tray
18 07613336146644 08106568001 08106568001 LXG EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE 1 AVENIO Millisect
19 04015630925537 03121453001 03121453001 JJF ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE 1 COBAS® TaqMan®
20 00875197006421 09040897190 09040897190 PAB Cytomegalovirus (cmv) dna quantitative assay 3 cobas® CMV
21 00875197006131 08244049190 08244049190 cobas Babesia
22 00875197005776 07460066190 07460066190 MKZ,LSL,OOI DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA,real ti DNA PROBE, NUCLEIC ACID AMPLIFICATION, CHLAMYDIA,DNA-REAGENTS, NEISSERIA,real time Nucleic acid amplification system 1 cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems
23 00875197005752 07460155190 07460155190 MAQ Kit, Dna Detection, Human Papillomavirus 3 cobas HPV for use on the cobas 6800/8800 systems
24 00875197004939 07001037190 07001037190 PAB Cytomegalovirus (cmv) dna quantitative assay 3 cobas CMV Control Kit
25 00875197004069 2 05923450190 MZF Test, hiv detection 2 COBAS® TaqMan® HIV-1 Test version 2.0, For Use With the High Pure System
26 00875197004045 2.0 05969484190 cobas® TaqScreen MPX Test, v2.0
27 00875197003260 05235898190 05235898190 MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 cobas® 4800 HPV Amplification/Detection Kit
28 00875197003253 05235880190 05235880190 MAQ KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS 3 cobas® 4800 HPV Amplification/Detection Kit
29 00875197003024 2 05212308190 MZF Test, hiv detection 2 COBAS® AmpliPrep/ COBAS® TaqMan® HIV- 1 Test, version 2.0
30 00875197002676 05002125190 05002125190 cobas® TaqScreen Cadaveric Specimen Diluent Kit
31 00875197002218 04404220190 04404220190 cobas® TaqScreen Wash Reagent
32 00875197002003 03577163190 03577163190 MKT Hepatitis Viral B DNA Detection 3 COBAS® TaqMan® HBV Test, For Use With The High Pure System
33 00875197001099 2 03322114018 COBAS® AmpliScreen HIV-1 Test, v1.5
34 00875197000030 20759899123 20759899123 COBAS® AMPLICOR Wash Buffer
35 07613336193297 09341935001 09341935001 GWW Ataxiagraph 1 Floodlight MS Draw Shape Test
36 07613336193280 09341927001 09341927001 GWW Ataxiagraph 1 Floodlight MS Draw Shape Test
37 07613336193259 09341889001 09341889001 GWW Ataxiagraph 1 Floodlight MS Pinching Test
38 07613336119563 07886977001 07886977001 OOI real time Nucleic acid amplification system 2 cobas Liat Software Version 3.0
39 04038377020556 03502295001 03502295001 MKT Hepatitis Viral B DNA Detection 3 High Pure System Viral Nucleic Acid Kit
40 00875197006490 09040919190 09040919190 PAB Cytomegalovirus (cmv) dna quantitative assay 3 cobas® CMV Control Kit
41 00875197006483 09040536190 09040536190 MZF Test, HIV detection 2 cobas® HIV-1/HIV- 2 192T
42 00875197006445 09051554190 09051554190 MZF Test, HIV detection 2 cobas® NHP Negative Control Kit
43 00875197006261 08688206190 08688206190 QLX Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA 2 cobas&#x00AE EBV
44 00875197005264 1.0 06768253190 OQO Herpes Simplex Virus Nucleic Acid Amplification Assay 2 cobas® 4800 System Lysis Kit
45 00875197004229 06471463190 06471463190 OWD Somatic gene mutation detection system 3 cobas® EGFR Mutation Test
46 00875197004182 2 05989060190 MZP ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS ASSAY,HYBRIDIZATION AND/OR NUCLEIC ACID AMPLIFICATION FOR DETECTION OF HEPATITIS C RNA,HEPATITIS C VIRUS 2 COBAS® TaqMan® HCV Test For Use With the High Pure System
47 00875197004137 05985579190 05985579190 OWD Somatic gene mutation detection system 3 cobas® 4800 BRAF V600 Mutation Test
48 00875197002102 03599779190 03599779190 COBAS® AmpliScreen HBV Test
49 00875197001051 03302555018 03302555018 COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit
50 07613336193273 09341919001 09341919001 PTY Computerized Cognitive Assessment Aid, Exempt 2 Floodlight MS Cognitive Test
Other products with the same Product Code "OCC"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 07613336129685 08085463001 08085463001 cobas® Liat® Influenza A/B Script ROCHE MOLECULAR SYSTEMS, INC.
2 07332940006044 XPRSFLU-10 XPRSFLU-10 Xpert Xpress Flu kit; 10 test kit Xpert Xpress Flu CEPHEID
3 07332940005696 XPRSFLU/RSV-10 XPRSFLU/RSV-10 Xpert Xpress Flu/RSV kit; 10 test kit Xpert Xpress Flu/RSV CEPHEID
4 07332940005177 GXFLU+RSV-XP-10 GXFLU+RSV-XP-10 Xpert Flu+RSV Xpress kit; 10 test kit Xpert Flu+RSV Xpress CEPHEID
5 07332940001070 GXFLU-10A GXFLU-10A Xpert Flu kit; 10 test kit Xpert Flu CEPHEID
6 07332940000783 GXFLU/RSV-10 GXFLU/RSV-10 Xpert FLU/RSV XC kit; 10 test kit Xpert FLU/RSV XC CEPHEID
7 04053228033905 V1 691221 QIAstat-Dx® Respiratory Panel QIAGEN GMBH
8 03573026403997 69-010B-US ADENOVIRUS R-gene® KIT US is a RT-PCR test is to aid in the diagnosis of respira ADENOVIRUS R-gene® KIT US is a RT-PCR test is to aid in the diagnosis of respiratory Adenovirus infection in humans in conjunction with other clinical and laboratory findings. ARGENE® ADENOVIRUS R-gene KIT US BIOMERIEUX SA
9 00875197005950 08160104190 08160104190 cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System ROCHE MOLECULAR SYSTEMS, INC.
10 00875197005653 07402686190 07402686190 cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System ROCHE MOLECULAR SYSTEMS, INC.
11 00875197005639 07402660190 07402660190 cobas® Influenza A/B Quality Control Kit for use on the cobas® Liat® System ROCHE MOLECULAR SYSTEMS, INC.
12 00875197005608 07341890190 07341890190 cobas® Influenza A/B Nucleic acid test for use on the cobas® Liat® System ROCHE MOLECULAR SYSTEMS, INC.
13 00857573006324 20-011-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. Respiratory Pathogens Flex (RP Flex) Amplification Tray NANOSPHERE, INC.
14 00857573006294 20-011-020 The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. Respiratory Virus Plus (RV+) Amplification Tray NANOSPHERE, INC.
15 00857573006263 20-009-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. Respiratory Pathogens Flex (RP Flex) Extraction Tray NANOSPHERE, INC.
16 00857573006232 20-009-020 The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. Respiratory Virus Plus (RV+) Extraction Tray NANOSPHERE, INC.
17 00857573006164 20-006-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a mult The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge NANOSPHERE, INC.
18 00857573006133 20-006-020 The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene The Verigene® Respiratory Virus Plus Nucleic Acid Test (RV+) on the Verigene® System is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify multiple respiratory virus nucleic acids in nasopharyngeal (NP) swab specimens from individuals with signs and symptoms of respiratory tract infection. Respiratory Virus Plus (RV+) Nucleic Acid Test Cartridge NANOSPHERE, INC.
19 00857167005030 ePlex Respiratory Panel (RP) EA001012 ePlex Respiratory Panel Kit, 12 test, IVD ePlex System GENMARK DIAGNOSTICS, INC.
20 00857167005023 ePlex Respiratory Panel (RP) KT022006 ePlex Sample Delivery Device RP Panel ePlex System GENMARK DIAGNOSTICS, INC.
21 00857167005016 ePlex Respiratory Panel (RP) KT022287 Respiratory Panel Cartridge ePlex System GENMARK DIAGNOSTICS, INC.
22 00851458005112 1.5 FLM1-ASY-0121 NGDS FilmArray Instrument FILMARRAY BIOFIRE DEFENSE, LLC
23 00851458005068 JRPD-ASY-0137 JRPD-ASY-0137 JBAIDS IVD Influenza A & B Detection Kit JBAIDS BIOFIRE DEFENSE, LLC
24 00851034007073 01 63-R0001 In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of res In-vitro multiplex assay used with the Biocode MDx 3000 for the detection of respiratory pathogens. BioCode Respiratory Pathogen Panel APPLIED BIOCODE, INC.
25 00840487101711 20-011-024 20-011-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multip The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. Respiratory Pathogens Flex (RP Flex) Amplification Tray LUMINEX CORPORATION
26 00840487101667 20-009-024 20-009-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multip The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. Respiratory Pathogens Flex (RP Flex) Extraction Tray LUMINEX CORPORATION
27 00840487101612 20-006-024 20-006-024 The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multip The Verigene® Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) is a multiplexed qualitative test intended for the simultaneous detection and identification of multiple viral and bacterial nucleic acids in nasopharyngeal swabs (NPS) obtained from individuals suspected of respiratory tract infection. Respiratory Pathogens Flex (RP Flex) Nucleic Acid Test Cartridge LUMINEX CORPORATION
28 00840487100486 I025C0197 I025C0197 The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid The xTAG® Respiratory Viral Panel Fast (RVP FAST) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected ofrespiratory tract infections xTAG® RVP FAST (Respiratory Viral Panel Fast) LUMINEX MOLECULAR DIAGNOSTICS, INC
29 00840487100462 I019C0111 I019C0111 The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex The xTAG® Respiratory Viral Panel (RVP) is a qualitative nucleic acid multiplex test intended for the simultaneous detection and identification of multiple respiratory virus nucleic acids in nasopharyngeal swabs from individuals suspected of respiratory tract infections. xTAG® RVP (Respiratory Viral Panel) LUMINEX MOLECULAR DIAGNOSTICS, INC
30 00840487100417 I051C0447 I051C0447 The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on The NxTAG® Respiratory Pathogen Panel is a qualitative test intended for use on the Luminex® MAGPIX® instrument for the simultaneous detection and identification of nucleic acids from multiple respiratory viruses and bacteria extracted from nasopharyngeal swabs collected from individuals with clinical signs and symptoms of a respiratory tract infection. NxTAG® Respiratory Pathogen Panel LUMINEX MOLECULAR DIAGNOSTICS, INC
31 00840487100158 50-10020 The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualit The ARIES® Flu A/B & RSV Assay is a polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) nucleic acid in nasopharyngeal swabs (NPS) specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings. ARIES® Flu A/B & RSV Assay LUMINEX CORPORATION
32 00815381020161 RFIT-ASY-0130 RFIT-ASY-0130 IVD reagent kit containing 6 tests FilmArray® Respiratory Panel 2 (RP2) BIOFIRE DIAGNOSTICS, LLC
33 00815381020154 RFIT-ASY-0129 RFIT-ASY-0129 IVD reagent kit containing 30 tests FilmArray® Respiratory Panel 2 (RP2) BIOFIRE DIAGNOSTICS, LLC
34 00815381020147 RFIT-ASY-0120 RFIT-ASY-0120 IVD reagent kit containing 30 tests. FilmArray® Respiratory Panel (RP) EZ BIOFIRE DIAGNOSTICS, LLC
35 00815381020079 RFIT-ASY-0125 RFIT-ASY-0125 IVD reagent kit containing 6 tests. FilmArray® Respiratory Panel (RP) BIOFIRE DIAGNOSTICS, LLC
36 00815381020062 RFIT-ASY-0124 RFIT-ASY-0124 IVD reagent kit containing 30 tests. FilmArray® Respiratory Panel (RP) BIOFIRE DIAGNOSTICS, LLC
37 B540FAB1100CWC0 FAB1100CW-C FAB1100CW-1 The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qua The Accula™ Flu A / B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Accula™ Flu A / B Test. Accula Flu A / B Control Kit MESA BIOTECH, INC.
38 B540FAB1100CW0 FAB1100CW FAB1100CW The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro The Accula™ Flu A / B Test performed on the Accula Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Accula Flu A / B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Accula Flu A / B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus. Accula Flu A / B Test MESA BIOTECH, INC.
39 B540D20010 D2001 D2001 The Programming Cassette is an accessory to the Accula Dock and facilitates repr The Programming Cassette is an accessory to the Accula Dock and facilitates reprogramming of the Dock’s embedded firmware. When firmware updates are needed, the firmware will be stored onto Programming Cassettes and sent to end users, who will load the Programming Cassette into their Dock and re-program its firmware Accula Programming Cassette MESA BIOTECH, INC.
40 B540D20000 D2000 D2000 The Accula Dock is an electronic module which executes in vitro diagnostic tests The Accula Dock is an electronic module which executes in vitro diagnostic tests on compatible Test Cassettes. It consists of anelectro-mechanical interface to a single Test Cassette. The Dock contains all electrical systems, controls and logic necessary toorchestrate in-vitro diagnostic tests within the inserted Test Cassette. Accula Dock MESA BIOTECH, INC.
41 B54010400 1040 1040 The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro dia The Silaris™ RSV Test performed on the Silaris™ Dock is a molecular in vitro diagnostic test utilizing polymerase chainreaction (PCR) and lateral flow technologies for the qualitative, visual detection of respiratory syncytial virus (RSV) viral RNA.The Silaris RSV Test uses a nasal swab specimen collected from patients with signs and symptoms of respiratory infection.The Silaris RSV Test is intended as an aid in the diagnosis of RSV infection in children and adults in conjunction with clinicaland epidemiological risk factors. Silaris RSV Supplemental Pack MESA BIOTECH, INC.
42 B54010350 1035 1035 The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus. Sialris Influenza A&B Supplemental Pack MESA BIOTECH, INC.
43 B54010290 1029 1029 The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality c The Silaris RSV Control Kit is intended for in vitro diagnostic use in quality control testing with the Silaris RSV Test Silaris RSV Control Kit MESA BIOTECH, INC.
44 B54010280 1028 1028 The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) The Silaris Starter Pack contains two (2) Silaris Influenza A&B kits and one (1) Silaris Dock for the purposes of starting up a clinical location. SilarisTM Influenza A&B Starter Pack MESA BIOTECH, INC.
45 B54010270 1027 1027 The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in The Silaris™ Influenza A&B Test performed on the Silaris Dock is a molecular in vitro diagnostic test utilizing polymerasechain reaction (PCR) and lateral flow technology for the qualitative, visual detection and differentiation of influenza A andinfluenza B viral RNA. The Silaris Influenza A&B Test uses a nasal swab specimen collected from patients with signs andsymptoms of respiratory infection. Silaris Influenza A&B assay is intended as an aid in the diagnosis of influenza infectionsin conjunction with clinical and epidemiological risk factors. The assay is not intended to detect the presence of influenzaC virus. Silaris Influenza A&B Test MESA BIOTECH, INC.
46 B54010240 1024 1024 The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use i The Silaris™ Influenza A&B Control Kit is intended for in vitro diagnostic use in qualitycontrol testing with the Silaris™ Influenza A&B Test. Silaris Influenza A&B Control Kit MESA BIOTECH, INC.
47 30014613336143 M306 M306 Solana RSV/hMPB Assay Solana DIAGNOSTIC HYBRIDS, INC.
48 30014613336068 M300 M300 Solana Infulenza A+B Assay Solana DIAGNOSTIC HYBRIDS, INC.
49 30014613311133 Adenovirus Assay M113 Lyra Adenovirus Assay Lyra QUIDEL CORPORATION
50 30014613311034 M103 M103 Lyra RSV+HMPV Assay Lyra DIAGNOSTIC HYBRIDS, INC.