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® 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 | 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 | |
8 | 00875197004120 | 05985536190 | 05985536190 | OWD | Somatic gene mutation detection system | 3 | cobas® DNA Sample Preparation Kit | |
9 | 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 | |
10 | 00875197003185 | 05235804190 | 05235804190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 System Sample Preparation Kit | |
11 | 00875197003178 | 05235782190 | 05235782190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 System Sample Preparation Kit | |
12 | 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 | |
13 | 00875197001068 | 2 | 03302563018 | COBAS® AmpliScreen HCV Test, v2.0 | ||||
14 | 00875197000993 | 2 | 03155935018 | MTL | MONITOR,TEST,HIV-1 | 3 | COBAS AMPLICOR HIV-1 Monitor Test, version 1.5 | |
15 | 08430215046203 | 03531414001 | 03531414001 | OOI | real time Nucleic acid amplification system | 2 | LightCycler® 2.0 Instrument | |
16 | 07613336171295 | 08988218001 | 08988218001 | JQW | STATION, PIPETTING AND DILUTING, FOR CLINICAL USE | 1 | cobas® prime Secondary Tube Tray | |
17 | 07613336146644 | 08106568001 | 08106568001 | LXG | EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE | 1 | AVENIO Millisect | |
18 | 04015630925537 | 03121453001 | 03121453001 | JJF | ANALYZER, CHEMISTRY, MICRO, FOR CLINICAL USE | 1 | COBAS® TaqMan® | |
19 | 00875197006421 | 09040897190 | 09040897190 | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | cobas® CMV | |
20 | 00875197006131 | 08244049190 | 08244049190 | cobas Babesia | ||||
21 | 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 | |
22 | 00875197005752 | 07460155190 | 07460155190 | MAQ | Kit, Dna Detection, Human Papillomavirus | 3 | cobas HPV for use on the cobas 6800/8800 systems | |
23 | 00875197004939 | 07001037190 | 07001037190 | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | cobas CMV Control Kit | |
24 | 00875197004069 | 2 | 05923450190 | MZF | Test, hiv detection | 2 | COBAS® TaqMan® HIV-1 Test version 2.0, For Use With the High Pure System | |
25 | 00875197004045 | 2.0 | 05969484190 | cobas® TaqScreen MPX Test, v2.0 | ||||
26 | 00875197003260 | 05235898190 | 05235898190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 HPV Amplification/Detection Kit | |
27 | 00875197003253 | 05235880190 | 05235880190 | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | cobas® 4800 HPV Amplification/Detection Kit | |
28 | 00875197003024 | 2 | 05212308190 | MZF | Test, hiv detection | 2 | COBAS® AmpliPrep/ COBAS® TaqMan® HIV- 1 Test, version 2.0 | |
29 | 00875197002676 | 05002125190 | 05002125190 | cobas® TaqScreen Cadaveric Specimen Diluent Kit | ||||
30 | 00875197002218 | 04404220190 | 04404220190 | cobas® TaqScreen Wash Reagent | ||||
31 | 00875197002003 | 03577163190 | 03577163190 | MKT | Hepatitis Viral B DNA Detection | 3 | COBAS® TaqMan® HBV Test, For Use With The High Pure System | |
32 | 00875197001099 | 2 | 03322114018 | COBAS® AmpliScreen HIV-1 Test, v1.5 | ||||
33 | 00875197000030 | 20759899123 | 20759899123 | COBAS® AMPLICOR Wash Buffer | ||||
34 | 07613336193297 | 09341935001 | 09341935001 | GWW | Ataxiagraph | 1 | Floodlight MS Draw Shape Test | |
35 | 07613336193280 | 09341927001 | 09341927001 | GWW | Ataxiagraph | 1 | Floodlight MS Draw Shape Test | |
36 | 07613336193259 | 09341889001 | 09341889001 | GWW | Ataxiagraph | 1 | Floodlight MS Pinching Test | |
37 | 07613336119563 | 07886977001 | 07886977001 | OOI | real time Nucleic acid amplification system | 2 | cobas Liat Software Version 3.0 | |
38 | 04038377020556 | 03502295001 | 03502295001 | MKT | Hepatitis Viral B DNA Detection | 3 | High Pure System Viral Nucleic Acid Kit | |
39 | 00875197006490 | 09040919190 | 09040919190 | PAB | Cytomegalovirus (cmv) dna quantitative assay | 3 | cobas® CMV Control Kit | |
40 | 00875197006483 | 09040536190 | 09040536190 | MZF | Test, HIV detection | 2 | cobas® HIV-1/HIV- 2 192T | |
41 | 00875197006445 | 09051554190 | 09051554190 | MZF | Test, HIV detection | 2 | cobas® NHP Negative Control Kit | |
42 | 00875197006261 | 08688206190 | 08688206190 | QLX | Nucleic acid amplification test for the quantitation of Epstein-Barr virus (EBV) DNA | 2 | cobas® EBV | |
43 | 00875197005264 | 1.0 | 06768253190 | OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 2 | cobas® 4800 System Lysis Kit | |
44 | 00875197004229 | 06471463190 | 06471463190 | OWD | Somatic gene mutation detection system | 3 | cobas® EGFR Mutation Test | |
45 | 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 | |
46 | 00875197004137 | 05985579190 | 05985579190 | OWD | Somatic gene mutation detection system | 3 | cobas® 4800 BRAF V600 Mutation Test | |
47 | 00875197002102 | 03599779190 | 03599779190 | COBAS® AmpliScreen HBV Test | ||||
48 | 00875197001051 | 03302555018 | 03302555018 | COBAS® AmpliScreen Multiprep Specimen Preparation and Control Kit | ||||
49 | 07613336193273 | 09341919001 | 09341919001 | PTY | Computerized Cognitive Assessment Aid, Exempt | 2 | Floodlight MS Cognitive Test | |
50 | 07613336193266 | 09341897001 | 09341897001 | PTY | Computerized Cognitive Assessment Aid, Exempt | 2 | Floodlight MS Cognitive Test |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 08885013950021 | 400125 | 400125 | The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplifica The Sentosa SA201 Real-Time PCR Instrument is a real-time nucleic acid amplification and detection system. It measures nucleic acid signals from reverse transcribed RNA and converts the signals to comparative quantitative readouts using fluorescent detection of dual-labeled hydrolysis probes. | Sentosa SA201 Real-Time PCR Instrument | VELA OPERATIONS SINGAPORE PTE. LTD. |
2 | 08809537070751 | A-2061 | A-2061 | Exicycler™ 384 | BIONEER CORPORATION | |
3 | 08809537070034 | A-2060-1 | A-2060-1 | Exicycler™ 96 | BIONEER CORPORATION | |
4 | 08800204300690 | KM005 | RADI PCR 96 Plus | KH MEDICAL CO., LTD. | ||
5 | 08800204300096 | KM002 | The RADI CHAMP260 is a stand-alone automated isothermal amplification and detec The RADI CHAMP260 is a stand-alone automated isothermal amplification and detection system for target nucleic acid sequences found in human specimens. The instrument is used in conjunction with KH Medical’s LOOP-Mediated Amplification in vitro diagnostic products.RADI CHAMP260 is designed to freely manipulate specific temperature and running time for amplification of samples by 7 inch touch screen.Amplification of target DNA occurs during the heat cycle and results in the formation of precipitate detected by the RADI CHAMP260 optics system. The precipitate generated by the presence of amplified target DNA leads to a turbid Sample/Control reaction solution which is then measured by absorbance. The RADI CHAMP260 uses the change in turbidity of each Sample/Control reaction solution to report assay results as INVALID, POSITIVE, or NEGATIVE on the 7 inch touch screen. | RADI CHAMP260 | KH MEDICAL CO., LTD. | |
6 | 08430215046203 | 03531414001 | 03531414001 | LightCycler® 2.0 Instrument | ROCHE MOLECULAR SYSTEMS, INC. | |
7 | 07613336179970 | 09260994001 | 09260994001 | cobas® Liat® Analyzer Software 3.3 | ROCHE MOLECULAR SYSTEMS, INC. | |
8 | 07613336156926 | 08415129001 | 08415129001 | cobas Liat Software v3.1.1 Update Key for cobas Liat Analyzer | ROCHE MOLECULAR SYSTEMS, INC. | |
9 | 07613336156551 | 08403864001 | 08403864001 | cobas Liat Influenza AB Script Version 1.33 | ROCHE MOLECULAR SYSTEMS, INC. | |
10 | 07613336150047 | 08302375001 | 08302375001 | cobas Liat Influenza A/B Script Version 1.32 | ROCHE MOLECULAR SYSTEMS, INC. | |
11 | 07613336148259 | 08276412001 | 08276412001 | cobas Liat Analyzer Software 3.2 | ROCHE MOLECULAR SYSTEMS, INC. | |
12 | 07613336142738 | 08153248001 | 08153248001 | cobas Liat System Software v3.1 Update Key for cobas Liat Analyzer | ROCHE MOLECULAR SYSTEMS, INC. | |
13 | 07613336119570 | 07886985001 | 07886985001 | cobas Liat Advanced Tools Key | ROCHE MOLECULAR SYSTEMS, INC. | |
14 | 07613336119563 | 07886977001 | 07886977001 | cobas Liat Software Version 3.0 | ROCHE MOLECULAR SYSTEMS, INC. | |
15 | 07613336100097 | 07341920190 | 07341920190 | cobas Liat Analyzer | ROCHE MOLECULAR SYSTEMS, INC. | |
16 | 07332940006822 | INFINITY48-16 | 900-0453 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 | GeneXpert® | CEPHEID |
17 | 07332940007720 | GX-INFINITY 80 | GX-INFINITY 80 | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 | GeneXpert® | CEPHEID |
18 | 07332940007713 | GX-INFINITY 48S | GX-INFINITY 48S | Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s Xpert MTB/RIF Assay, GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, GeneXpert Infinity-80 | GeneXpert® | CEPHEID |
19 | 07332940007706 | GX-XVI R2 | GX-XVI R2 | XPERT, GENEXPERT DX SYSTEM | GeneXpert® | CEPHEID |
20 | 07332940007690 | GX-IV R2 | GX-IV R2 | XPERT, GENEXPERT DX SYSTEM | GeneXpert® | CEPHEID |
21 | 07332940007683 | GX-II R2 | GX-II R2 | XPERT, GENEXPERT DX SYSTEM | GeneXpert® | CEPHEID |
22 | 07332940007195 | GXIV-HUB | 900-0828 | Xpress System | GeneXpert® | CEPHEID |
23 | 07332940006860 | INFINITY 48-48 | 900-0457 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Infinity-80 System | CEPHEID |
24 | 07332940006853 | INFINITY 48-40 | 900-0456 | Additional catalog number: 900-0456R | GeneXpert Infinity-80 System | CEPHEID |
25 | 07332940006846 | INFINITY 48-32 | 900-0455 | Additional catalog number: 900-0455R | GeneXpert Infinity-80 System | CEPHEID |
26 | 07332940006839 | INFINITY 48-24 | 900-0454 | Additional catalog number: 900-0454R | GeneXpert Infinity-80 System | CEPHEID |
27 | 07332940006815 | GXIV-1 | 900-0425 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
28 | 07332940006761 | GXXVI-4 | 900-0398 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
29 | 07332940006754 | GXXVI-8 | 900-0397 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
30 | 07332940006747 | GXXVI-16 | 900-0395 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
31 | 07332940006730 | GXXVI-12 | 900-0391 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
32 | 07332940006723 | GXIV-3 | 900-0144 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
33 | 07332940006716 | GXIV-1 | 900-0141 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
34 | 07332940006709 | GXIV-3 | 900-0139 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
35 | 07332940004408 | GXXVI-4-R | 900-0518R | Certified Pre-Owned GeneXpert Dx System | CEPHEID | |
36 | 07332940004392 | GXXVI-8-R | 900-0519R | Certified Pre-Owned GeneXpert Dx System | CEPHEID | |
37 | 07332940004385 | GXXVI-12-R | 900-0520R | Certified Pre-Owned GeneXpert Dx System | CEPHEID | |
38 | 07332940004378 | GXXVI-16-R | 900-0521R | Certified Pre-Owned GeneXpert Dx System | CEPHEID | |
39 | 07332940004361 | GX-I | 900-0523 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
40 | 07332940004354 | INFINITY48-16 | 900-0536 | GeneXpert Infinity-48s System | CEPHEID | |
41 | 07332940004347 | INFINITY48-24 | 900-0537 | GeneXpert Infinity-48s System | CEPHEID | |
42 | 07332940004330 | INFINITY 48-32 | 900-0538 | GeneXpert Infinity-48s System | CEPHEID | |
43 | 07332940004323 | INFINITY 48-40 | 900-0539 | GeneXpert Infinity-48s System | CEPHEID | |
44 | 07332940004316 | INFINITY 48-48 | 900-0540 | Additional catalog numbers: 900-0540L, 900-0540R | GeneXpert Infinity-48s System | CEPHEID |
45 | 07332940004309 | GXII-2 | 900-0542 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
46 | 07332940004194 | GX-I | 900-0423 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
47 | 07332940004170 | GXIV-2 | 900-0424 | Additional catalog number: 900-0424R | GeneXpert Dx System | CEPHEID |
48 | 07332940004163 | GXXVI-16 | 900-0426 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
49 | 07332940004156 | GXXVI-12 | 900-0427 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |
50 | 07332940004149 | GXXVI-8, GXXVI-12 | 900-0428 | XPERT, GENEXPERT DX SYSTEM | GeneXpert Dx System | CEPHEID |