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 "PTY"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 B626200020 20002 Research Platform LINUS HEALTH, INC.
2 B626200010 20001 20001 Core Cognitive Evaluation is a non-invasive test that assess possible cognitive Core Cognitive Evaluation is a non-invasive test that assess possible cognitive impairment. It is intended to be used by medical professionals qualified to interpret results of a cognitive assessment. Core Cognitive Evaluation LINUS HEALTH, INC.
3 B62611100 1110 1110 DCTclock System DCTclock LINUS HEALTH, INC.
4 B626100960 10096 10096 DCTclock System - Research DCTclock LINUS HEALTH, INC.
5 B626100930 10093 10093 DCTclock Practice Test Form - clinical DCTclock LINUS HEALTH, INC.
6 B626100720 10072 10072 DCTclock Test Form - Clinical DCTclock LINUS HEALTH, INC.
7 B626100410 10041 10041 DCTclock Uploader Software DCTclock LINUS HEALTH, INC.
8 B626100390 10039 10039 DCTclock Practice Test Form - Research DCTclock LINUS HEALTH, INC.
9 B626100150 10015 10015 DCTclock Cloud Platform DCTclock LINUS HEALTH, INC.
10 B626100060 10006 10006 DCTclock Micro USB Cable DCTclock LINUS HEALTH, INC.
11 B626100050 10005 10005 DCTclock Dock DCTclock LINUS HEALTH, INC.
12 B626100040 10004 10004 DCTclock Digital Pen DCTclock LINUS HEALTH, INC.
13 B626100030 10003 10003 DCTclock Test Form - Research DCTclock LINUS HEALTH, INC.
14 07613336193273 09341919001 09341919001 Floodlight MS Cognitive Test ROCHE MOLECULAR SYSTEMS, INC.
15 07613336193266 09341897001 09341897001 Floodlight MS Cognitive Test ROCHE MOLECULAR SYSTEMS, INC.
16 07290016986143 AT-910 (A10tion) VRCBT AT-910 The AT-910 ("A10tion") is a is a virtual reality, immersive therapeuticapplicati The AT-910 ("A10tion") is a is a virtual reality, immersive therapeuticapplication, indicated to train and improve cognitive function of patients withdiagnosed ADHD. This application is a clinician- monitored program and should beconsidered for use as part of the therapeutic program that include clinician directedtherapyThis multidimensional training program application targetsattention, executive function and memory combined with motor activationthrough the use of games and entertainment features. VRCBT XR HEALTH IL LTD
17 07290016986112 CT-620 (Memorize) A software-only medical device intended to aid mitigate or assess conditions rel A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-620 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-620 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device. VRCogni XR HEALTH IL LTD
18 07290016986105 CT-610 (Re-Act) A software-only medical device intended to aid mitigate or assess conditions rel A software-only medical device intended to aid mitigate or assess conditions related to cognitive function by providing cognitive exercises and cognitive ability measurements. The cognitive exercises and cognitive ability measurements rely on inputs from visual and auditory stimuli, and functional use of the hands and enable guiding patients in the performance of various cognitive exercises, tracking and analyzing motion and movement kinematics and monitoring changes in patient's measurements over time.The CT-610 is a prescription-only device that can be used in clinical setting or at home, with or without the assistance of clinician. CT-610 is not intended to be used for diagnosis, treatment, decision making, or as a stand-alone device. VRCogni XR HEALTH IL LTD
19 G134NS200 2.0 NeuroCatch Platform software NS20 NeuroCatch Platform NEUROCATCH INC
20 G134NCP21 2.0 NCP2 NeuroCatch Platform systemREF: NCP2 NeuroCatch Platform NEUROCATCH INC
21 G134NCEB1 2.0 NCEB Earbuds used for the NeuroCatch Platform (REF NCP2) NeuroCatch Platform NEUROCATCH INC
22 G134NCCPS1 2.0 NCCPS NeuroCatch EEG Cap, size Small for use with the NeuroCatch Platform system NeuroCatch EEG Cap NEUROCATCH INC
23 G134NCCPM1 2.0 NCCPM NeuroCatch EEG Cap, size Medium for use with the NeuroCatch Platform system NeuroCatch EEG Cap NEUROCATCH INC
24 G134NCCPL1 2.0 NCCPL NeuroCatch EEG Cap, size Largefor use with the NeuroCatch Platform system NeuroCatch EEG Cap NEUROCATCH INC
25 G134NCCP1 2.0 NCCP EEG Cap used for the NeuroCatch PlatformSizes SML, MED, LRG. NeuroCatch Platform NEUROCATCH INC
26 03665099000002 Version 1 The HappyNeuron Cognitive Training provides users with a program that is designe The HappyNeuron Cognitive Training provides users with a program that is designed to be adapted for patientssuffering from cognitive impairments linked to chronic diseases. Two programs have been designed so fartargeting specific conditions: Multiple Sclerosis and Rheumatoid Arthritis.The cognitive training is a combination of scheduled workouts and on-demand complementary exercises.It contains computerized exercises that stimulate cognitive abilities (Memory, Attention, Language, ExecutiveFunctions and Visual-Spatial Skills). Coaching features guide the users through the exercises, adapt thedifficulty settings dynamically, and follow-up on performance. Happyneuron Cognitive Training HAPPYNEURON
27 00884838108554 6.0.x.x 821401000000 Philips IntelliSpace Cognition (ISC) is a digital assessment platform that suppo Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report. INTELLISPACE™ COGNITION PHILIPS ELECTRONICS NEDERLAND B.V.
28 00884838104587 5.0.x.x 821401000000 Philips IntelliSpace Cognition (ISC) is a digital assessment platform that suppo Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report. INTELLISPACE™ COGNITION PHILIPS ELECTRONICS NEDERLAND B.V.
29 00884838103900 4.0.x.x 821401000000 Philips IntelliSpace Cognition (ISC) is a digital assessment platform that suppo Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report. INTELLISPACE™ COGNITION PHILIPS ELECTRONICS NEDERLAND B.V.
30 00884838103535 3.0.x.x 821401000000 Philips IntelliSpace Cognition (ISC) is a digital assessment platform that suppo Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report. INTELLISPACE™ COGNITION PHILIPS ELECTRONICS NEDERLAND B.V.
31 00884838101036 2.0.x.x Philips IntelliSpace Cognition (ISC) is a digital assessment platform that suppo Philips IntelliSpace Cognition (ISC) is a digital assessment platform that supports Healthcare Professionals in assessing the cognition of individuals. It is a cloud-based Software as a Service consisting of both a patient interface on a tablet and a clinician interface that can be used on any PC or tablet. The patient uses a digital pencil on the tablet to complete a cognitive assessment. The application immediately scores the tests, compares to norms and displays the results in terms of cognitive domains as part of a comprehensive report. INTELLISPACE™ COGNITION PHILIPS ELECTRONICS NEDERLAND B.V.
32 00884838098244 1.1.X 821401000000 INTELLISPACE™ COGNITION PHILIPS ELECTRONICS NEDERLAND B.V.
33 00864127000332 1 Cognitive Impairment Screener IMPACT APPLICATIONS, INC.
34 00860334002114 4.5 The ANAM Test System is a software only device that provides clinicians with obj The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance to aid in the assessment of an individual’s level of cognitive performance. The ANAM Test System provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain a more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.The ANAM Test System provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test result to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Test System will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available. ANAM Test System VISTA PARTNERS, LLC
35 00860334002107 4.3 The ANAM Test System: Military Battery (ANAM Military Battery) is a software onl The ANAM Test System: Military Battery (ANAM Military Battery) is a software only device that provides clinicians with objective measurements of cognitive performance in military populations, to aid in the assessment of an individual's level of cognitive function. The ANAM Military Battery provides precise, objective, and repeatable automated measures of neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, and decision processing speed and efficiency. It can be used to screen for general cognitive impairment within initial triage assessment/decision making or to obtain more refined and detailed information regarding a person’s neurocognitive status. The battery is also specially designed for longitudinal assessment of cognitive functioning and can be used 1) to monitor progression of disease status; 2) to track cognitive change or recovery; and 3) to monitor the cognitive effects of medical interventions.The ANAM Military Battery provides both absolute and relative information about the test taker’s performance. Test performance following an injury, event, or intervention can be assessed by comparing a person’s test results to a previous testing point or to a pre-existing “baseline” if those data are available. If pre-existing testing data are unavailable, the ANAM Military Battery will provide a comparison of performance in relationship to a selected normative/reference group. The ANAM Performance Report software program will automatically provide comparisons to selectable reference groups as well as to the test taker’s previous testing data, if available. ANAM Test System: Military Battery VISTA PARTNERS, LLC
36 00860007318740 SNP-GOG-21 Cognition Snapshot+ 2.1.0 QR8 HEALTH INC
37 00860007318733 CHR-COG-10 Cognition Chronicle QR8 HEALTH INC
38 00860007318726 CHR-COG-W10 Chronicle Web QR8 HEALTH INC
39 00860007318719 SNP-COG-20 Cognition Snapshot v2.0 QR8 HEALTH INC
40 00860007318702 SNP-COG-10 Cognition Snapshot QR8 HEALTH INC
41 00860000709408 1.0 The Brain Gauge MD is a computerized cognitive assessment aid that assesses cogn The Brain Gauge MD is a computerized cognitive assessment aid that assesses cognitive function based on the perception of simple taps and vibrations delivered to the fingertips of the patient's hand. Brain Gauge MD CORTICAL METRICS, LLC
42 00860000564038 Portable Device Cognivue Thrive COGNIVUE, INC.
43 00860000564021 Portable Device Cognivue Clarity COGNIVUE, INC.
44 00850017250093 95P-0014 95P-0014 The Bertec Vision Trainer System (BVT) is a device that objectively measures the The Bertec Vision Trainer System (BVT) is a device that objectively measures the performance of subject’s visuo-motor skills. It consists of a large touchscreen monitor, a force plate, and the BVT software. The subject interacts with the screen by touching and/or moving their center of pressure in response to a target stimulus, both dynamic and static. Bertec Vision Trainer System (BVT) BERTEC CORPORATION
45 00815962020634 BITS-3355 Bioness Integrated Therapy System Version 3.0 Motion Sensor BITS Motion Sensor BIONESS INC.
46 00815962020627 BITS-3155 BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit Bioness Integrated Therapy System, BITS 3.0, BITS Balance BIONESS INC.
47 00815962020610 BITS-3055 Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS S Bioness Integrated Therapy System Version 3.0, Hardware It - 55" Display, BITS Software Kit, BITS PC Kit, BITS Balance Accessory Kit, and BITS Balance Platform Kit Bioness Integrated Therapy System, BITS 3.0, BITS Balance BIONESS INC.