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 | 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 | 00054749005529 | 04P75-03 | i-STAT 1 Wireless | i-STAT | ABBOTT POINT OF CARE INC. | |
2 | 00054749005222 | 03P75-90 | i-Stat 1 Wireless Analyzer | i-STAT | ABBOTT POINT OF CARE INC. | |
3 | 00054749005215 | 03P75-89 | i-Stat 1 Wireless Analyzer | i-STAT | ABBOTT POINT OF CARE INC. | |
4 | 00054749005208 | 03P75-88 | i-Stat 1 Wireless Analyzer | i-STAT | ABBOTT POINT OF CARE INC. | |
5 | 00054749005192 | 03P75-87 | i-Stat 1 Wireless Analyzer | i-STAT | ABBOTT POINT OF CARE INC. | |
6 | 00054749005185 | 03P75-86 | i-Stat 1 Wireless Analyzer | i-STAT | ABBOTT POINT OF CARE INC. | |
7 | 00054749005178 | 03P75-85 | i-Stat 1 Wireless Analyzer | i-STAT | ABBOTT POINT OF CARE INC. | |
8 | 00054749005161 | 03P75-84 | i-Stat 1 Wireless Analyzer | i-STAT | ABBOTT POINT OF CARE INC. | |
9 | 00054749005154 | 03P75-83 | i-Stat 1 Wireless Analyzer | i-STAT | ABBOTT POINT OF CARE INC. | |
10 | 00054749005147 | 03P75-82 | i-Stat 1 Wireless Analyzer | i-STAT | ABBOTT POINT OF CARE INC. | |
11 | 00054749005123 | 03P75-81 | i-Stat 1 Wireless Analyzer | i-STAT | ABBOTT POINT OF CARE INC. | |
12 | 00054749005093 | 03P75-07 | i-STAT 1 Wireless | i-STAT | ABBOTT POINT OF CARE INC. | |
13 | 10054749005519 | 09P31-26 | Cartridge, Chem8+ | i-STAT | ABBOTT POINT OF CARE INC. | |
14 | 10054749005502 | 03P85-51 | Cartridge, CG4+ | i-STAT | ABBOTT POINT OF CARE INC. | |
15 | 04053228043560 | 2 | 874721 | The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR te The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument. | therascreen® FGFR RGQ RT-PCR Kit | QIAGEN GMBH |
16 | 04053228035725 | 1 | 874821 | The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitati The therascreen BRAF V600E RGQ PCR Kit is a real-time PCR test for the qualitative detection of V600E mutations in the BRAF gene using genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) human colorectal cancer (CRC) tumor tissue. The therascreen BRAF V600E RGQ PCR Kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mCRC) whose tumors carry the BRAF V600E mutation for treatment with BRAFTOVI (encorafenib) in combination with cetuximab. The therascreen BRAF V600E RGQ PCR Kit is for use on the Rotor-Gene Q MDx (US)instrument. The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use. | therascreen® BRAF RGQ PCR Kit | QIAGEN GMBH |
17 | 04053228034223 | V1 | 873121 | The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the d The therascreen PIK3CA RGQ PCR Kit is a real-time qualitative PCR test for the detection of 11 mutations in the phosphatidylinositol 3-kinase catalytic subunit alpha (PIK3CA) gene (Exon 7: C420R; Exon 9: E542K, E545A, E545D [1635G>T only], E545G, E545K, Q546E, Q546R; and Exon 20: H1047L, H1047R, H1047Y) using genomic DNA (gDNA) extracted from formalin-fixed, paraffin-embedded (FFPE) breast tumor tissue or circulating tumor DNA (ctDNA) from plasma derived from K2EDTA anticoagulated peripheral whole blood taken from patients with breast cancer. The test is intended to aid clinicians in identifying breast cancer patients who may be eligible for treatment with PIQRAY® (alpelisib) based on a PIK3CA Mutation Detected result. Patients whose FFPE tissue or plasma specimen produces a positive therascreen PIK3CA RGQ PCR Kit test result for the presence of one or more PIK3CA mutations are eligible for treatment with PIQRAY (alpelisib). Patients whose plasma specimen produces a negative result using this test should be reflexed to testing with FFPE tumor tissue for the presence of PIK3CA mutations. FFPE tumor specimens are processed using the QIAamp DSP DNA FFPE Tissue Kit for manual sample preparation. K2EDTA anticoagulated whole peripheral venous blood plasma specimens are processed using the QIAamp DSP Circulating Nucleic Acid Kit for manual sample preparation. For both specimen types, the Rotor-Gene Q (RGQ) MDx (US) instrument is used for automated amplification and detection. The Kit is to be used by trained personnel in a professional laboratory environment. | therascreen® PIK3CA RGQ PCR Kit | QIAGEN GMBH |
18 | 04053228034094 | V1 | 874721 | The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR te The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffin-embedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib).Specimens are processed using the RNeasy DSP FFPE Kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the Rotor-Gene Q MDx (US) instrument. | therascreen® FGFR RGQ RT-PCR Kit | QIAGEN GMBH |
19 | 04053228002062 | 1 | 870121 | therascreen® EGFR RGQ PCR Kit | QIAGEN GMBH | |
20 | 04053228002048 | 1 | 870021 | therascreen® KRAS RGQ PCR Kit | QIAGEN GMBH | |
21 | 03573026559823 | 1.0 | Software used in combination with the THxIDTM- BRAF assay(used to identify patie Software used in combination with the THxIDTM- BRAF assay(used to identify patients with melanoma whose tumors harbor the BRAF V600E/K mutations) | THxID™ BRAF | BIOMERIEUX SA | |
22 | 03573026354909 | 410697 | 410697 | The THxID™ BRAF kit is an IVD real time PCR device intended for the qualitative The THxID™ BRAF kit is an IVD real time PCR device intended for the qualitative detection of the BRAF V600E and V600K mutations in human melanoma tissue | THxID™-BRAF | BIOMERIEUX SA |
23 | 00884999047792 | 08N90-006 | 08N90-006 | Abbott RealTime IDH1m2000rt Application CD-ROM | RealTime | ABBOTT MOLECULAR INC. |
24 | 00884999047358 | 08N90-090 | 08N90-090 | Abbott RealTime IDH1 Amplification Reagent Kit | RealTime | ABBOTT MOLECULAR INC. |
25 | 00884999047341 | 08N90-080 | 08N90-080 | Abbott RealTime IDH1 Control Kit | RealTime | ABBOTT MOLECULAR INC. |
26 | 00884999047051 | 08N82-080 | Abbott RealTime IDH2 Control Kit | RealTime | ABBOTT MOLECULAR INC. | |
27 | 00884999047044 | 08N82-090 | 08N82-090 | Abbott RealTime IDH2 Amplification Reagent Kit | RealTime | ABBOTT MOLECULAR INC. |
28 | 00884999047037 | 08N82-001 | 08N82-001 | Abbott RealTime IDH2 m2000rt Application CD-ROM | RealTime | ABBOTT MOLECULAR INC. |
29 | 00875197005592 | 7258321190 | 07258321190 | cobas® EZH2 Mutation Test | ROCHE MOLECULAR SYSTEMS, INC. | |
30 | 00875197005448 | 2.0 | 07248563190 | cobas® EGFR Mutation Test v2 | ROCHE MOLECULAR SYSTEMS, INC. | |
31 | 00875197004229 | 06471463190 | 06471463190 | cobas® EGFR Mutation Test | ROCHE MOLECULAR SYSTEMS, INC. | |
32 | 00875197004199 | 1.0 | 05852170190 | cobas® KRAS Mutation Test | ROCHE MOLECULAR SYSTEMS, INC. | |
33 | 00875197004137 | 05985579190 | 05985579190 | cobas® 4800 BRAF V600 Mutation Test | ROCHE MOLECULAR SYSTEMS, INC. | |
34 | 00875197004120 | 05985536190 | 05985536190 | cobas® DNA Sample Preparation Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
35 | 00850052003739 | 850052003739 | K4120361 | The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test d The LeukoStrat CDx FLT3 Mutation Assay is a PCR-based in vitro diagnostic test designed to detect internal tandem duplication (ITD) and tyrosine kinase domain (TKD) mutations D835 and I836 in the FLT3 gene in genomic DNA extracted from mononuclear cells obtained from peripheral blood or bone marrow aspirates of patients diagnosed with acute myelogenous leukemia (AML). | LeukoStrat | INVIVOSCRIBE, INC. |
36 | 00850052003685 | 850052003685 | K4120221 | The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to ident The LeukoStrat CDx FLT3 Mutation Assay targets regions of the FLT3 gene to identify internal tandem duplication (ITD) mutations and tyrosine kinase domain (TKD) mutations, such as the D835 and I836 mutations. The LeukoStrat CDx FLT3 Mutation Assay includes reagents, equipment, software and procedures for isolating mononuclear cells and extracting DNA from patient specimens to determine if FLT3 mutations are present. DNA is amplified via PCR, TKD amplicon is enzymatically digested, and the amplicons are detected via capillary electrophoresis. | LeukoStrat | INVIVOSCRIBE, INC. |