| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 04053228006442 | 1 | 19073 | PPM | General Purpose Reagent | 1 | Buffer AVL | |
| 2 | 04053228040996 | V1 | 1124264 | The CMV Probe ASR contains a specific nucleic acid sequence for detection of Cyt The CMV Probe ASR contains a specific nucleic acid sequence for detection of Cytomegalovirus (CMV). The CMV Probe ASR is designed to detect a region of the MIE gene in the CMV genome. The DNA is synthetically derived.Analyte Specific Reagent. Analytical and performance characteristics are not established. | MVU | Reagents, Specific, Analyte | 1 | CMV Probe ASR |
| 3 | 04053228039129 | 1 | 9003070 | The QIAcube Connect MDx system is a fully automated, sample preparation system, The QIAcube Connect MDx system is a fully automated, sample preparation system, processing up to 12 samples using silica spin columns technology. The QIAcube Connect MDx is intended to be used only in combination with QIAGEN kits indicated for use with the QIAcube Connect MDx system for the protocols described in the instructions for use of the respective kits. The system is intended for use by professional users, such as technicians and physicians trained in molecular biological techniques and the operation of the QIAcube Connect IVD system. | JJH | Clinical Sample Concentrator | 1 | QIAcube Connect MDx |
| 4 | 04053228010760 | 1 | 9001492 | JJH | Clinical Sample Concentrator | 1 | EZ1 Advanced XL | |
| 5 | 04053228010739 | 1 | 9001297 | JJH | Clinical Sample Concentrator | 1 | QIAsymphony SP | |
| 6 | 04053228004592 | 1 | 937236 | JJH | Clinical Sample Concentrator | 1 | QIAsymphony DSP DNA Mini Kit | |
| 7 | 04053228004431 | 1 | 1067392 | MVU | Reagents,Specific,Analyte | 1 | BK Virus Probe ASR | |
| 8 | 04053228004417 | 1 | 1066155 | MVU | Reagents,Specific,Analyte | 1 | HSV-1 Probe ASR | |
| 9 | 04053228002918 | 1 | 61904 | JJH | Clinical Sample Concentrator | 1 | QIAamp DSP Viral RNA Mini Kit | |
| 10 | 04053228001850 | 1 | 937156 | JJH | Clinical Sample Concentrator | 1 | QIAsymphony DSP AXpH DNA Kit | |
| 11 | 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. | OWD | Somatic Gene Mutation Detection System | 3 | therascreen® FGFR RGQ RT-PCR Kit |
| 12 | 04053228040972 | V1 | 1124260 | The CMV Primer ASR contains a specific nucleic acid sequence for the amplificati The CMV Primer ASR contains a specific nucleic acid sequence for the amplification of cytomegalovirus (CMV). The CMV Primer ASR is designed to detect a 105 bp region of the MIE gene in the CMV genome. The DNA is synthetically derived.Analyte Specific Reagent. Analytical and performance characteristics are not established. | MVU | Reagents, Specific, Analyte | 1 | CMV Primer ASR |
| 13 | 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. | OWD | Somatic Gene Mutation Detection System | 3 | therascreen® FGFR RGQ RT-PCR Kit |
| 14 | 04053228024538 | 1 | 4503346 | PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | 3 | artus® CMV QS-RGQ MDx Kit | |
| 15 | 04053228010753 | 1 | 9001411 | JJH | Clinical Sample Concentrator | 1 | EZ1 Advanced | |
| 16 | 04053228004585 | 1 | 937055 | JJH | Clinical Sample Concentrator | 1 | QIAsymphony DSP Virus/Pathogen Midi Kit | |
| 17 | 04053228002901 | 1 | 61704 | JJH | Clinical Sample Concentrator | 1 | QIAamp DSP Virus Spin Kit | |
| 18 | 04053228002895 | 2 | 61304 | JJH | Clinical Sample Concentrator | 1 | QIAamp DSP DNA Mini Kit | |
| 19 | 04053228002871 | 1 | 60404 | JJH | Clinical Sample Concentrator | 1 | QIAamp DSP DNA FFPE Tissue Kit | |
| 20 | 04053228002062 | 1 | 870121 | OWD | Somatic Gene Mutation Detection System | 3 | therascreen® EGFR RGQ PCR Kit | |
| 21 | 04053228010746 | 1 | 9001301 | OOI | Real Time Nucleic Acid Amplification System | 2 | QIAsymphony AS | |
| 22 | 04053228010722 | 1 | 9001292 | JJH | Clinical Sample Concentrator | 1 | QIAcube | |
| 23 | 04053228001898 | 1 | 937255 | JJH | Clinical Sample Concentrator | 1 | QIAsymphony DSP DNA Midi Kit | |
| 24 | 04053228015444 | V1 | 673633 | PSU | Jak2 Gene Mutation Detection Test | 2 | ipsogen® JAK2 RGQ PCR Kit | |
| 25 | 04053228004646 | 1 | 4572346 | OZN | C.Difficile Toxin Gene Amplification Assay | 2 | artus® C. difficile QS-RGQ MDx Kit | |
| 26 | 04053228004400 | 1 | 1067295 | OHQ | Multi-Analyte Controls Unassayed | 1 | VZV Positive Control | |
| 27 | 04053228002086 | 1 | 4503245 | PAB | Cytomegalovirus (Cmv) Dna Quantitative Assay | 3 | artus® CMV RGQ MDx Kit | |
| 28 | 04053228004660 | 1 | 4526346 | OQO | Herpes Simplex Virus Nucleic Acid Amplification Assay | 2 | artus® HSV-1/2 QS-RGQ MDx Kit | |
| 29 | 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. | OWD | Somatic Gene Mutation Detection System | 3 | therascreen® PIK3CA RGQ PCR Kit |
| 30 | 04053228004356 | 1 | 1067287 | MVU | Reagents,Specific,Analyte | 1 | VZV Primer ASR | |
| 31 | 04053228004578 | 1 | 937036 | JJH | Clinical Sample Concentrator | 1 | QIAsymphony DSP Virus/Pathogen Mini Kit | |
| 32 | 04053228000099 | 4 | 62724 | JJH | Clinical Sample Concentrator | 1 | EZ1 DSP Virus Kit | |
| 33 | 04053228000075 | 2 | 61104 | JJH | Clinical Sample Concentrator | 1 | QIAamp DSP DNA Blood Mini Kit | |
| 34 | 04053228004387 | 1 | 1066176 | OHQ | Multi-Analyte Controls Unassayed | 1 | HSV Positive Control | |
| 35 | 04053228004370 | 1 | 1066160 | MVU | Reagents,Specific,Analyte | 1 | HSV-2 Probe ASR | |
| 36 | 04053228004363 | 1 | 1066150 | MVU | Reagents,Specific,Analyte | 1 | HSV Primer ASR | |
| 37 | 04053228004448 | 1 | 1067395 | OHQ | Multi-Analyte Controls Unassayed | 1 | BK Virus Positive Control | |
| 38 | 04053228002963 | 1 | 61504 | JJH | Clinical Sample Concentrator | 1 | QIAamp DSP Circulating DNA Kit | |
| 39 | 04053228002048 | 1 | 870021 | OWD | Somatic Gene Mutation Detection System | 3 | therascreen® KRAS RGQ PCR Kit | |
| 40 | 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. | OWD | Somatic Gene Mutation Detection System | 3 | therascreen® BRAF RGQ PCR Kit |
| 41 | 04053228010821 | 1 | 6000-3101 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | Rapid Capture System | |
| 42 | 04053228003519 | 1 | 9001923 | JQW | Station, Pipetting And Diluting, For Clinical Use | 1 | QIAensemble Decapper System | |
| 43 | 04053228002758 | 1 | 19134 | PPM | General Purpose Reagent | 1 | QIAGEN Proteinase K | |
| 44 | 04053228000068 | 1 | 60704 | JJH | Clinical Sample Concentrator | 1 | QIAamp DSP Virus Kit | |
| 45 | 04053228039150 | 1 | 19089 | Viral Lysis Buffer | PPM | General Purpose Reagent | 1 | Buffer AVL (w/o carrier RNA, 155 ml) |
| 46 | 04053228010838 | 1 | 9002035 | OOI | Real Time Nucleic Acid Amplification System | 2 | Rotor-Gene® Q MDx | |
| 47 | 04053228004394 | 1 | 1067291 | MVU | Reagents,Specific,Analyte | 1 | VZV Probe ASR | |
| 48 | 04053228033936 | v1 | 9002824 | Additional Catalog Numbers:9002814 QIAstat-Dx Analytical Module9002813 QIAstat-D Additional Catalog Numbers:9002814 QIAstat-Dx Analytical Module9002813 QIAstat-Dx Operational ModuleDI Numbers:QIAstat-Dx Analytical Module DI Number: 04053228033929QIAstat-Dx Operational Module DI Number: 04053228033936 | OOI | Real Time Nucleic Acid Amplification System | 2 | QIAstat-Dx® Analyzer 1.0 |
| 49 | 04053228033905 | V1 | 691221 | OZZ,OQW,OZY,OZX,OTG,OOI,OEP,OOU,OEM,OCC | Bordetella Pertussis Dna Assay System,2009 H1n1 Influenza Virus (Swine Origin), Bordetella Pertussis Dna Assay System,2009 H1n1 Influenza Virus (Swine Origin), Nucleic Acid Or Antigen, Detection And Identification,Chlamydophila Pneumoniae Dna Assay System,Mycoplasma Pneumoniae Dna Assay System,Non-Sars Coronavirus Multiplex Nucleic Acid Assay,Real Time Nucleic Acid Amplification System,Influenza A Virus Subtype Differentiation Nucleic Acid Assay,Parainfluenza Multiplex Nucleic Acid Assay,Human Metapneumovirus (Hmpv) Rna Assay System,Respiratory Virus Panel Nucleic Acid Assay System | 2 | QIAstat-Dx® Respiratory Panel | |
| 50 | 04053228004561 | 3 | 62124 | JJH | Clinical Sample Concentrator | 1 | EZ1 DSP DNA Blood Kit |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 00842768028441 | 10385332 | LKPM | For use in daily maintenance of the IMMULITE® and IMMULITE® 1000 systems | IMMULITE® Probe Cleaning Kit | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 2 | 00842768028434 | 10385229 | L2KPM | For use in daily maintenance of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers | IMMULITE 2000/XPi Probe Cleaning Kit | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 3 | 00842768028427 | 10385231 | L2PWSM | For use in the routine operation of the IMMULITE® 2000 and IMMULITE® 2500 Analyzers | IMMULITE 2000/XPi Probe Wash Module | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 4 | 00842768028410 | 10385393 | LPWS2 | For use in the routine operation of the IMMULITE® and IMMULITE® 1000 Analyzers | IMMULITE® Probe Wash Module | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| 5 | 00819704020258 | 3428 | 3428 | SEEKER™ Personal Computer | SEEKER™ | BAEBIES, INC. |
| 6 | 00819704020241 | 3145 | 3145 | SEEKER™ Personal Computer | SEEKER™ | BAEBIES, INC. |
| 7 | 00819704020234 | 3132 | 3132 | SEEKER™ Personal Computer | SEEKER™ | BAEBIES, INC. |
| 8 | 00816565021547 | 55161 | ereader working with ecup +. 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD ereader working with ecup +. 13 Drug Detection: AMP,MET,MDMA,BAR,BZO,BUP,COCMTD,OPI,6AM,OXY,PCP,THC3 Adulteration Test: pH,CRE,Ni. | eREADER+ Drug Screening Instrument | AMEDITECH INC. | |
| 9 | 00816467020372 | Pro System | 08000067, 08000067-R, 08000067-X | RoHS Compliant 7-chamber FastPack System | FastPack® Pro System | QUALIGEN INC. |
| 10 | 00816467020334 | IP System | 08000043-C, 08000043-CR | RoHS Compliant FastPack System | FastPack® IP System | QUALIGEN INC. |
| 11 | 00816467020006 | IP System | 08000043, 08000043-R, 08000043-X | FastPack® IP System | QUALIGEN INC. | |
| 12 | 00816057020058 | NC-2700-000 | NC-2700-000 | EIA microtiter plate analyzer | ASI Infinity Analyzer | ARLINGTON SCIENTIFIC, INC. |
| 13 | 00725609000267 | 910-0500-00 | 910-0500-00 | SPOTCHECK Pro | SPOTCHECK | ASTORIA-PACIFIC, INC. |
| 14 | 00690286000063 | 833073 | An instrument used to interpret and report the results of the PROFILE®-V MEDTOXS An instrument used to interpret and report the results of the PROFILE®-V MEDTOXScan® Test Devices, which are one-step immunochromatographic tests for the rapid, qualitative detection of one or more drugs in human urine. | MEDTOXScan® Reader | MEDTOX DIAGNOSTICS, INC. | |
| 15 | 00657498000397 | G7700S-001 | G7700S-001 | This instrument is intended to be used to read and calculate the results of in-v This instrument is intended to be used to read and calculate the results of in-vitro clinical diagnostic assays, as well as any other application requiring absorbance or concentration readings at or near the available wavelengths. This general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate features and options for each specific clinical application. | Excel® Chemistry Analyzer (Spanish) | STANBIO LABORATORY, L.P. |
| 16 | 00657498000380 | G7700E-001 | G7700E-001 | This instrument is intended to be used to read and calculate the results of in-v This instrument is intended to be used to read and calculate the results of in-vitro clinical diagnostic assays, as well as any other application requiring absorbance or concentration readings at or near the available wavelengths. This general purpose instrument is intended to be used by laboratory professionals capable of selecting the appropriate features and options for each specific clinical application. | Excel® Chemistry Analyzer | STANBIO LABORATORY, L.P. |
| 17 | 00630414965017 | 10385394 | LSUBX | Substrate Module - IMMULITE - CONS - 2x500 Tests | IMMULITE®/IMMULITE® 1000 Systems SUBS | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD |
| 18 | 00607158000113 | 70-1064-0 | 70-1064-0 | The DPP® Micro Reader for use with the DPP Zika IgM Assay System is a reflectanc The DPP® Micro Reader for use with the DPP Zika IgM Assay System is a reflectance reader configured to read exclusive results of the DPP Zika IgM test cartridge, through the application of an RFID tag applied to one side of the reader, which carries the DPP Zika test configuration. Once configured, the reader measures the intensity of the control and analyte lines on the test device, and shows the test results on the LCD display. The DPP Micro Reader minimizes human errors due to subjective visual interpretation; therefore, the operator cannot visually interpret the results of DPP Assay Devices made to be read with a DPP Micro Reader; they must be read exclusively with the DPP Micro Reader. | DPP Zika IgM Micro Reader | CHEMBIO DIAGNOSTIC SYSTEMS INC. |
| 19 | 00404847452525 | HYB-5252 | HYB-5252 | The DRG:HYBRiD-XL® is a fully automated random access analyzer.The innovative te The DRG:HYBRiD-XL® is a fully automated random access analyzer.The innovative technology of the DRG:HYBRiD-XL® allows users to simultaneously process immunoassays and clinical chemistry parameters, including turbidimetry, on one or more patient samples.The DRG:HYBRiD-XL® can be used for both the quantitative and qualitative (cut-off) evaluation of immunoassays. | DRG:HYBRiD.XL® | DRG INSTRUMENTS GESELLSCHAFT MIT BESCHRÄNKTER HAFTUNG |
| 20 | 00382902560661 | 256066 | 256066 | BD Veritor™ Plus Analyzer | BD Veritor™ Plus Analyzer | BECTON, DICKINSON AND COMPANY |
| 21 | 00382902560555 | 256055 | 256055 | BD Veritor™ System Reader | BD Veritor™ System Reader | BECTON, DICKINSON AND COMPANY |
| 22 | 15420045506862 | SYSCHECK, INSTRUMENT VERIFICATION SOLUTI | 301078 | SysCheck | HOLOGIC, INC. | |
| 23 | 10837461002529 | iChem®10SG Urine Chemistry Strips | 800-7005 | iChem®10 SG Urine Chemistry Strips | iChem | IRIS INTERNATIONAL, INC. |
| 24 | 10743816001362 | LSR-2000 | LSR-2000-00 | Dxpress Reader/1 Unit | Dxpress Reader | PRINCETON BIOMEDITECH CORPORATION |
| 25 | 09120052071146 | 30183570 00 | 30183570 | The Infinite F50 Plus is an absorbance microplate reader for ELISA. It includes The Infinite F50 Plus is an absorbance microplate reader for ELISA. It includes Magellan™ reader control and data analysis software. | Infinite F50 Plus | TECAN AUSTRIA GMBH |
| 26 | 09120052070521 | 30050303 01 | 30050303 | microplate reader | INFINITE 200 PRO | TECAN AUSTRIA GMBH |
| 27 | 09120052070439 | 30087530 01 | 30087530 | The Infinite F50 ROBOTIC is an absorbance microplate reader for ELISA. It includ The Infinite F50 ROBOTIC is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software.It is intended to be integrated in robotic solutions. | Infinite F50 ROBOTIC FS | TECAN AUSTRIA GMBH |
| 28 | 09120052070422 | 30087509 01 | 30087509 | The Infinite F50 ROBOTIC is an absorbance microplate reader for ELISA. It includ The Infinite F50 ROBOTIC is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software.It is intended to be integrated in robotic solutions. | Infinite F50 ROBOTIC | TECAN AUSTRIA GMBH |
| 29 | 09120052070415 | 30087508 01 | 30087508 | The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magel The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software. | Infinite F50 | TECAN AUSTRIA GMBH |
| 30 | 09120052070408 | 30087506 01 | 30087506 | microplate reader - intended to be integrated in robotic solutions | SUNRISE-RC/6F EVOLYZER | TECAN AUSTRIA GMBH |
| 31 | 09120052070392 | 30087505 01 | 30087505 | microplate reader - intended to be integrated in robotic solutions | SUNRISE-RC/TW EVOLYZER | TECAN AUSTRIA GMBH |
| 32 | 09120052070385 | 30087504 01 | 30087504 | microplate reader - intended to be integrated in robotic solutions | SUNRISE-RC/ST EVOLYZER | TECAN AUSTRIA GMBH |
| 33 | 09120052070361 | 30087502 01 | 30087502 | microplate reader | SUNRISE | TECAN AUSTRIA GMBH |
| 34 | 09120052070347 | 30084265 01 | 30084265 | The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magel The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software. | Infinite F50 | TECAN AUSTRIA GMBH |
| 35 | 09120052070040 | 30048684 01 | 30048684 | The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magel The Infinite F50 is an absorbance microplate reader for ELISA. It includes Magellan™for Infinite F50 reader control and data analysis software. | Infinite F50 | TECAN AUSTRIA GMBH |
| 36 | 08437022431482 | 100033000US1 | 900033000US1 | The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.0) is an instrument spe The iPeak® reader 4,3” Lateral Flow Reader (SW Version 3.0) is an instrument specifically to be used to provide quantitative, semi-quantitative, and/or qualitative in-vitro determination of photometric immunochromatographic test defined and marketed by IUL’ partners. The iPeak® reader 4,3” is intended to be used only in combination with lateral flow (LF) tests indicated for use with the iPeak® reader 4,3”, and only for applications that are described in the respective handbooks of our reader associates. | iPeak® reader 4,3" Lateral Flow Reader | IUL SA |
| 37 | 07640158711514 | D16103000 | 5697449 | Blue light radiometer: An instrument designed to measure the radiant flux (radia Blue light radiometer: An instrument designed to measure the radiant flux (radiant power) in the spectral range of 400 to 500 nm (i.e., blue) during bilirubinemia treatment for newborns and infants | Giraffe PT Light Meter | DERUNGS LICHT AG |
| 38 | 07290016923223 | VS07000 | The BreathID® Smart System is intended for use to non-invasively measure changes The BreathID® Smart System is intended for use to non-invasively measure changes in the 13CO2/12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Smart System is indicated for use as an aid in the initial diagnosis and post treatment monitoring H. pylori of infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Smart System consists of the appropriate IDkit: Hp™ kit and the BreathID® Smart device. | BreathID Smart System | MERIDIAN BIOSCIENCE ISRAEL LTD | |
| 39 | 07290016923070 | VS01082 | The BreathID® Hp Lab System is intended for use to non-invasively measure change The BreathID® Hp Lab System is intended for use to non-invasively measure changes in the 13CO2/ 12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach. The BreathID® Hp Lab System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp Lab System consists of the appropriate IDkit: Hp™ kit, and the BreathID® Hp device, Auto Sampler and Lab Application | BreathID Hp Lab System | MERIDIAN BIOSCIENCE ISRAEL LTD | |
| 40 | 07290016923056 | VS01000 | VS01000 | The BreathID® Hp System is intended for use to continually and non-invasively me The BreathID® Hp System is intended for use to continually and non-invasively measure changes in the13CO2 /12CO2 ratio of exhaled breath, which may be indicative of increased urease production associated with active Helicobacter pylori (H. pylori) infection in the stomach.The BreathID® Hp System is indicated for use as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients and pediatric patients ages 3-17 years old. The BreathID® Hp System consists of the appropriate IDkit:Hp™ kit and the BreathID® Hp test device. | BreathID Hp System | MERIDIAN BIOSCIENCE ISRAEL LTD |
| 41 | 06438115000198 | 145218 | 145218 | QuikRead go® instrument has been designed to measure quantitative test results f QuikRead go® instrument has been designed to measure quantitative test results from patient samples using QuikRead go® reagent kits. | QuikRead go® Instrument | AIDIAN OY |
| 42 | 05700574037055 | SH1M-SI | Multi-Mode Microplate Reader | SH1M-SI | AGILENT TECHNOLOGIES, INC. | |
| 43 | 05700574037048 | SH1MG-SI | Multi-Mode Microplate Reader | SH1MG-SI | AGILENT TECHNOLOGIES, INC. | |
| 44 | 05700574037031 | SH1MF-SI | Multi-Mode Microplate Reader | SH1MF-SI | AGILENT TECHNOLOGIES, INC. | |
| 45 | 05700574037024 | SH1MFG-SI | Multi-Mode Microplate Reader | SH1MFG-SI | AGILENT TECHNOLOGIES, INC. | |
| 46 | 05700574037017 | SH1M2-SI | Multi-Mode Microplate Reader | SH1M2-SI | AGILENT TECHNOLOGIES, INC. | |
| 47 | 05700574037000 | SH1M2G-SI | Multi-Mode Microplate Reader | SH1M2G-SI | AGILENT TECHNOLOGIES, INC. | |
| 48 | 05700574036997 | SH1M2F-SI | Multi-Mode Microplate Reader | SH1M2F-SI | AGILENT TECHNOLOGIES, INC. | |
| 49 | 05700574036980 | SH1M2FG-SI | Multi-Mode Microplate Reader | SH1M2FG-SI | AGILENT TECHNOLOGIES, INC. | |
| 50 | 05700574036973 | SH1F-SI | Multi-Mode Microplate Reader | SH1F-SI | AGILENT TECHNOLOGIES, INC. |