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 | 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® 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® 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 |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 07613336160176 | 08106495001 | 08106495001 | AVENIO Millisect System PC | ROCHE MOLECULAR SYSTEMS, INC. | |
2 | 07613336146644 | 08106568001 | 08106568001 | AVENIO Millisect | ROCHE MOLECULAR SYSTEMS, INC. | |
3 | 07613336146620 | 08106550001 | 08106550001 | AVENIO Millisect Head Assembly | ROCHE MOLECULAR SYSTEMS, INC. | |
4 | 07613336146613 | 08106533001 | 08106533001 | AVENIO Millisect Fill Station | ROCHE MOLECULAR SYSTEMS, INC. | |
5 | 07613336146606 | 08106525001 | 08106525001 | AVENIO Millisect Tip Large | ROCHE MOLECULAR SYSTEMS, INC. | |
6 | 07613336146590 | 08106517001 | 08106517001 | AVENIO Millisect Tip Medium | ROCHE MOLECULAR SYSTEMS, INC. | |
7 | 07613336146583 | 08106509001 | 08106509001 | AVENIO Millisect Tip Small | ROCHE MOLECULAR SYSTEMS, INC. | |
8 | 07290016991062 | HemoCup | A disposable unit used for dispensing blood from a test tube. | HemoCup | PIXCELL MEDICAL TECHNOLOGIES LTD | |
9 | 06947462492247 | E1030 | Pipette Tip | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
10 | 06947462491738 | G1035 | Tube cover, 12mm, LDPE, blue | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
11 | 06947462491721 | G1034 | Tube cover, 12mm, LDPE, green | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
12 | 06947462491714 | H1014-3 | Tube cover, 16mm, LDPE, green | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
13 | 06947462491707 | G1032 | Tube cover, 12mm, LDPE, orange | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
14 | 06947462491691 | G1037 | Tube cover, 16mm, LDPE, Green | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
15 | 06947462491684 | G1036 | TEST TUBE, 16x85, PP, 9ml | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
16 | 06947462491677 | G1031 | Tube cover, 12mm, LDPE | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
17 | 06947462491660 | G1030 | TEST TUBE, 12x75, PP | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
18 | 06947462400259 | G10301 | TEST TUBE, 12x75, PP | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
19 | 06947462400228 | G1047W | Tube cover, 13x75, PE | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
20 | 06947462400204 | G1047 | Tube cover, 13x75, PE | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
21 | 06947462400198 | G1046 | TEST TUBE, 13x75, PP | Gongdong | ZHEJIANG GONGDONG MEDICAL TECHNOLOGY CO., LTD. | |
22 | 06438147325856 | 2081-0010 | 2081-0010 | Panthera-Puncher 9 is a sample transfer instrument for professional use. The sam Panthera-Puncher 9 is a sample transfer instrument for professional use. The sample, a dried blood disk, is extracted from a larger area of the sample (dried blood spot) by punching the disk of the specified size to a sample collection vessel, e.g. a 96-well microtiter plate. The identification of the sample punched to a specific well of the plate is stored and carried on to the next instrument or the data is transferred to the LIMS. Panthera-Puncher 9 is cabable of handling up to 9 pcs of 96-well microtiter plates simultaneously. Panthera-Puncher contains a camera for imaging of the sample card and for blood detection. | Panthera-Puncher 9 | WALLAC OY |
23 | 06438147064564 | 1296-026 | 1296-026 | 1296-026 DELFIA Platewash is a washer designed for automatic washing of microtit 1296-026 DELFIA Platewash is a washer designed for automatic washing of microtitration strips or plates. It is self-contained, having built-in pumps for vacuum and dispensing and supplied with all the bottles and tubing needed for operation. For use with DELFIA analytes, ready-made programs are accessible. | DELFIA Platewash | WALLAC OY |
24 | 06438147013890 | 1296-071 | 1296-071 | Wallac 1296-071 DBS Puncher is a microprocessor controlled automatic puncher for Wallac 1296-071 DBS Puncher is a microprocessor controlled automatic puncher for DELFIA® tests performed on filter paper in microplate format. It punches out a disk from a bloodspot on filter paper; this disk then falls into a microtitration well. Punch disk size depends on the punch head installed. Up to 99 disks can be punched into the same well. When the selected number of disks has been punched for a well, the plate is moved to the next position so that the next disk(s) can be punched out. Up to two plates can be loaded to DBS puncher. A microtitration 96-well format plate and Corning Costar deep well tray can be loaded at the same time. Plates consisting of twelve eight-well strips are also supported. | Wallac DBS Puncher | WALLAC OY |
25 | 05060456180348 | 62003 | 62003 | DIALISA 2MP, DS2 Automated ELISA Processing System | DIALISA 2MP | DYNEX TECHNOLOGIES, INC. |
26 | 05060456180317 | 62000 | 62000 | DS2 Automated ELISA Processing System | DYNEX DS2 | DYNEX TECHNOLOGIES, INC. |
27 | 05060456180287 | 65100 | 65100 | Automated ELISA Processing System with 0 Incubators | DYNEX DSX | DYNEX TECHNOLOGIES, INC. |
28 | 05060456180058 | 67000 | 67000 | Automated ELISA Processing System with 12 Incubators | DYNEX Agility | DYNEX TECHNOLOGIES, INC. |
29 | 05060456180003 | 62010 | 62010 | DS2 Automated ELISA Processing System, with Barcode Scanner | DYNEX DS2 | DYNEX TECHNOLOGIES, INC. |
30 | 05060246860375 | GastroCHECK | GASTROCEHCK-US | Measurement of Hydrogen, Methane and Oxygen levels in the exhaled breath. | Gastrolyzer | BEDFONT SCIENTIFIC LIMITED |
31 | 05060169691124 | CQ-Seal | ImCap Seal | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
32 | 05060169691117 | CQ-FULL | ImCap Rack | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
33 | 05060169691100 | IS-10DB | IDS-iSYS Diluent B | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
34 | 05060169691094 | IS-10DA | IDS-iSYS Diluent A | IMMUNODIAGNOSTIC SYSTEMS LIMITED | ||
35 | H10869433 | 6943 | 6943 | Corning X-Counterweight | Corning | CORNING INCORPORATED |
36 | H10869353 | 6935 | 6935 | Corning X-WASH Accesory kit | Corning | CORNING INCORPORATED |
37 | H10869333 | 6933 | 6933 | Corning X-WASH Disposable Cartridges (36 cartridges) | Corning | CORNING INCORPORATED |
38 | H10869323 | 6932 | 6932 | Corning X-WASH Disposable Cartridges (12 cartridges) | Corning | CORNING INCORPORATED |
39 | H10869313 | 6931 | 6931 | Corning X-WASH Disposable Cartridges (2 cartridges) | Corning | CORNING INCORPORATED |
40 | H10869293 | 6929 | 6929 | Corning X-WASH Docking Station | Corning | CORNING INCORPORATED |
41 | H10869283 | 6928 | 6928 | Corning X-WASH Control Module | Corning | CORNING INCORPORATED |
42 | H10869263 | 6926 | 6926 | Corning X-LAB Disposable Cartridges (36 cartridges) | Corning | CORNING INCORPORATED |
43 | H10869253 | 6925 | 6925 | Corning X-LAB Disposable Cartridges (12 cartridges) | Corning | CORNING INCORPORATED |
44 | H10869243 | 6924 | 6924 | Corning X-LAB Disposable Cartridges (2 cartridges) | Corning | CORNING INCORPORATED |
45 | H10869233 | 6923 | 6923 | Corning X-Balance Ring Kit | Corning | CORNING INCORPORATED |
46 | H10869223 | 6922 | 6922 | Corning X-Counterweight Low (Accessories) | Corning | CORNING INCORPORATED |
47 | H10869203 | 6920 | 6920 | Corning X-Counterweight High (Accessories) | Corning | CORNING INCORPORATED |
48 | H10869183 | 6918 | 6918 | Corning X-LAB Docking Station | Corning | CORNING INCORPORATED |
49 | H10869173 | 6917 | 6917 | Corning X-LAB Control Module | Corning | CORNING INCORPORATED |
50 | G338KIT0041 | 1 | KIT004 | This is the LEVL Starter package. | LEVL | MEDAMONITOR, LLC |