| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | 00382903406616 | 340661 | 340661 | BD® CD3 (SK7) APC | MVU | Reagents, specific, analyte | 1 | N/A |
| 2 | 30382903051954 | 305195 | 305195 | NEEDLE 18X1 RB | FMI | Needle, hypodermic, single lumen | N/A | |
| 3 | 30382903051756 | 305175 | 305175 | NEEDLE 20GA 1IN | FMI | Needle, hypodermic, single lumen | N/A | |
| 4 | 00382906654212 | 665421 | 665421 | Software Kit FACSDiva v9.2 IVD | OYE | Flow cytometric reagents and accessories. | 2 | FACSDiva |
| 5 | 00382906651273 | 665127 | 665127 | Ki-67 (B56) FITC ASR | MVU | Reagents, specific, analyte | 1 | N/A |
| 6 | 00382904910907 | 491090 | 491090 | BD FocalPoint Refurbished (120V) | MNM | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED | 3 | BD FocalPoint Slide Profiler Refurbished |
| 7 | 00382904429676 | 442967 | 442967 | BD Viper™ LT System PCR Accessory kit | MAQ | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS | 3 | BD Viper™ LT System PCR Accessory kit |
| 8 | 00382904429584 | 442958 | 442958 | BD Viper™ LT System SDA Accessory Kit | OOI | real time Nucleic acid amplification system | 2 | BD Viper™ LT System SDA Accessory Kit |
| 9 | 00382904428433 | 442843 | 442843 | BD Viper™ System, Remanufactured | LSL | DNA-REAGENTS, NEISSERIA | 2 | BD Viper™ System, Remanufactured |
| 10 | 00382904428211 | 442821 | 442821 | BD MAX™ ExK™ DNA-3 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | BD MAX™ ExK DNA-3 |
| 11 | 00382904428174 | 442817 | 442817 | BD MAX™ ExK™ DNA-1 | JJH | CLINICAL SAMPLE CONCENTRATOR | 1 | BD MAX™ ExK DNA-1 |
| 12 | 00382904428051 | 442805 | 442805 | BACTEC Blood Culture Procedural Tray | MDB | SYSTEM, BLOOD CULTURING | 1 | BD BACTEC™ Blood Culture Procedural Tray |
| 13 | 00382904462505 | 446250 | 446250 | BD Affirm™ Affirm VPIII Sample Collection Sets Contains: 1 each, Sterile S BD Affirm™ Affirm VPIII Sample Collection Sets Contains: 1 each, Sterile Swab, Sample Collection Tube, Sample Collection Tube Cap | LIO | Device, specimen collection | 1 | BD Affirm™ Affirm VPIII Sample Collection Sets |
| 14 | 00382904061401 | 406140 | 406140 | TRAY EPID SSHP20G3.5 L/PI X3742B | CAZ | Anesthesia conduction kit | 2 | BD perisafe, BD Epilor, BD Luer-Lok |
| 15 | 00382904061388 | 406138 | 406138 | TRAY EPID SSHP20G3.5 LOR5 L 2T0734 | CAZ | Anesthesia conduction kit | 2 | N/A |
| 16 | 00382904060770 | 406077 | 406077 | TRAY EPID SSTT17G3.5 LOR5 S/L | CAZ | Anesthesia conduction kit | 2 | N/A |
| 17 | 00382904060565 | 406056 | 406056 | TRAY EPID SSHP18G3.5 LOR5 S/L | CAZ | Anesthesia conduction kit | 2 | N/A |
| 18 | 00382904060558 | 406055 | 406055 | Tray EPID SSHP18G3.5 LOR5 L | CAZ | Anesthesia conduction kit | 2 | N/A |
| 19 | 00382904060305 | 406030 | 406030 | TRAY EPID SSTT17G3.5 LOR5 | CAZ | Anesthesia conduction kit | 2 | N/A |
| 20 | 00382904060251 | 406025 | 406025 | TRAY EPID CONT TT17G3.5 C19 | CAZ | Anesthesia conduction kit | 2 | N/A |
| 21 | 00382906651211 | 665121 | 665121 | CD223 (T47-530) PerCP-Cy5.5 ASR | MVU | Reagents, specific, analyte | 1 | N/A |
| 22 | 00382906651174 | 665117 | 665117 | CD152 (BNI3) PE ASR | MVU | Reagents, specific, analyte | 1 | N/A |
| 23 | 00382906651167 | 665116 | 665116 | CD42b (HIP1) PE ASR | MVU | Reagents, specific, analyte | 1 | N/A |
| 24 | 00382906645388 | 664538 | 664538 | BD® CD22 (S-HCL-1) PE-Cy7 | MVU | Reagents, specific, analyte | 1 | N/A |
| 25 | 00382906645371 | 664537 | 664537 | BD Horizon™ Mouse IgG1 (X40) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 26 | 00382906645364 | 664536 | 664536 | BD Horizon™ Anti-HLA-DR (G46-6) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 27 | 00382906645357 | 664535 | 664535 | BD Horizon™ CD45 (HI30) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 28 | 00382906645340 | 664534 | 664534 | BD Horizon™ CD23 (EBVCS-5) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 29 | 00382906645333 | 664533 | 664533 | BD Horizon™ CD20 (L27) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 30 | 00382906645326 | 664532 | 664532 | BD Horizon™ CD19 (SJ25C1) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 31 | 00382906645319 | 664531 | 664531 | BD Horizon™ CD16 (3G8) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 32 | 00382906645302 | 664530 | 664530 | BD Horizon™ CD8 (SK1) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 33 | 00382906645296 | 664529 | 664529 | BD Horizon™ CD5 (L17F12) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 34 | 00382906645289 | 664528 | 664528 | BD Horizon™ CD4 (SK3) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 35 | 00382906645272 | 664527 | 664527 | BD Horizon™ CD3 (SK7) BV786 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 36 | 00382906645265 | 664526 | 664526 | BD Horizon™ Mouse IgG1 (X40) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 37 | 00382906645258 | 664525 | 664525 | BD Horizon™ CD123 (9F5) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 38 | 00382906645241 | 664524 | 664524 | BD Horizon™ CD56 (NCAM16.2) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 39 | 00382906645234 | 664523 | 664523 | BD Horizon™ CD38 (HB7) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 40 | 00382906645227 | 664522 | 664522 | BD Horizon™ CD14 (MPhiP9) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 41 | 00382906645210 | 664521 | 664521 | BD Horizon™ CD13 (L138) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 42 | 00382906645203 | 664520 | 664520 | BD Horizon™ CD10 (HI10a) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 43 | 00382906645197 | 664519 | 664519 | BD Horizon™ CD4 (SK3) BV711 | MVU | Reagents, specific, analyte | 1 | Horizon |
| 44 | 00382906641267 | 664126 | 664126 | BD FACSCanto™ System Software | GKZ,OYE | Counter, differential cell,Flow cytometric reagents and accessories. | 2 | FACSCanto |
| 45 | 00382906641243 | 664124 | 664124 | BD FACSCanto™ II System Software | OYE,GKZ | Flow cytometric reagents and accessories.,Counter, differential cell | 2 | FACSCanto |
| 46 | 00382906641229 | 664122 | 664122 | BD FACSCanto™ System Software | GKZ | Counter, differential cell | 2 | FACSCanto |
| 47 | 00382906641199 | 664119 | 664119 | BD FACSCanto™ Clinical Software v4.0.1 | GKZ | Counter, differential cell | 2 | FACSCanto |
| 48 | 00382906641144 | 664114 | 664114 | BD FACSCanto™ System Software | GKZ | Counter, differential cell | 2 | FACSCanto |
| 49 | 00382906641120 | 664112 | 664112 | BD FACSCanto™ System Software | GKZ,OYE | Counter, differential cell,Flow cytometric reagents and accessories. | 2 | FACSCanto |
| 50 | 00382906641106 | 664110 | 664110 | BD FACSCanto™ II System Software | GKZ,OYE | Counter, differential cell,Flow cytometric reagents and accessories. | 2 | FACSCanto |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 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 | QIAstat-Dx® Analyzer 1.0 | QIAGEN GMBH |
| 2 | 04053228033905 | V1 | 691221 | QIAstat-Dx® Respiratory Panel | QIAGEN GMBH | |
| 3 | 04053228010838 | 1 | 9002035 | Rotor-Gene® Q MDx | QIAGEN GMBH | |
| 4 | 04053228010746 | 1 | 9001301 | QIAsymphony AS | QIAGEN GMBH | |
| 5 | 04015630929016 | 05200881001 | 05200881001 | cobas z 480 | ROCHE MOLECULAR SYSTEMS, INC. | |
| 6 | 03661540951947 | RTK403ING | RTK403ING | The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) base The HSV 1&2 ELITe MGB® Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of Herpes Simplex Virus 1 and 2 (HSV-1 and HSV-2) DNA in cutaneous or mucocutaneous lesion swab specimens from patients with signs and symptoms of HSV-1 or HSV-2 infection. | HSV 1&2 ELITe MGB Assay for CE-IVD | ELITECHGROUP MDX LLC |
| 7 | 03661540950001 | M800346 | MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct dete MRSA/SA ELITe MGB™ is a qualitative in vitro diagnostic test for the direct detection of Staphylococcus aureus (SA) and methicillin-resistant Staphylococcus aureus (MRSA) DNA purified from nasal swabs. MRSA/SA ELITe MGB™ is intended to aid in the prevention and control of MRSA infections in healthcare settings. It is not intended to diagnose MRSA infections or to guide or monitor treatment for MRSA infections. A negative result does not preclude MRSA/SA nasal colonization. Concomitant cultures are necessary to recover organisms for epidemiological typing or for further susceptibility testing. | MRSA/SA ELITe MGB | ELITECHGROUP MDX LLC | |
| 8 | 03661540900051 | F2102-000 | F2102-000 | The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides dispos The product «ELITe InGenius® Waste Box» (Catalog code F2102-000) provides disposable plastic boxes for collecting tip waste generated during the protocol run for extraction from biological samples, realtime set up in association with the «ELITe InGenius®» a fully automated sample-to-result instrument (Catalog code INT030-K).ELITe InGenius® Waste Box is FDA cleared only for use in association with ELITe InGenius® (Catalog code INT030-K) and HSV1&2 ELITe MGB® Assay. | ELITe InGenius® Waste Box | ELITECHGROUP SPA |
| 9 | 03661540900044 | INT032CS | The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides con The ELITe InGenius® SP 200 Consumable Set (Catalog number INT032CS) provides consumables to be used with ELITe InGenius® SP 200 (Catalog number INT032SP200) extraction cartridge for nucleic acid extraction from biological samples, in association with the ELITe InGenius® instrument (Catalog number INT030-K). ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection.ELITe InGenius® SP 200 Consumable Set is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay | ELITe InGenius® SP 200 Consumable Set | ELITECHGROUP SPA | |
| 10 | 03661540900037 | INT035PCR | INT035PCR | The product ELITe InGenius® PCR Cassette (catalog number INT035PCR) provides con The product ELITe InGenius® PCR Cassette (catalog number INT035PCR) provides consumables to be used in association with the ELITe InGenius® instrument (catalog number INT030-K) for Real Time PCR reactions. ELITe InGenius system, is a fully automated molecular diagnostics system performing extraction, purification, amplification and detection.ELITe InGenius® PCR Cassette is FDA cleared only for use in association with HSV1&2 ELITe MGB® Assay. | ELITe InGenius® PCR cassette | ELITECHGROUP SPA |
| 11 | 03661540900020 | INT032SP200 | INT032SP200 | The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP The product ELITe InGenius® SP 200 extraction cartridge (catalog number INT032SP200) provides reagents used in association with the ELITe InGenius® instrument (catalog number INT030-K) to perform extractions and purification of nucleic acids. ELITe InGenius system, is a fully automated molecular diagnostics system performingextraction, purification, amplification and detection.ELITe InGenius SP 200 is FDA cleared only for use in association with ELITe InGenius® (code INT030-K) instrument and HSV1&2 ELITe MGB® Assay. | ELITe InGenius® SP 200 | ELITECHGROUP SPA |
| 12 | 03661540900006 | INT030-K | INT030-K | The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that perform The ELITe InGenius® system is an in vitro diagnostic (IVD) platform that performs nucleic acid based tests. The ELITe InGenius system is a fully automated device integrating extraction and purification of nucleic acids from multiple sample types, amplification and detection of the target sequence by real-time Polymerase Chain Reaction (PCR), and result interpretation. ELITe InGenius® is FDA cleared only for use in association with HSV 1&2 ELITe MGB® Assay | ELITe InGenius® | ELITECHGROUP SPA |
| 13 | 01812125010067 | AC042 | AC042 | QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR QuantStudio Real-Time PCR Instrument Qualified by OpGen for use with Acuitas AMR Gene Panel. | Acuitas | OPGEN, INC. |
| 14 | 00884999049314 | 09N20-012 | 09N20-012 | Alinity m Bottle for Ethanol Use | Alinity m | ABBOTT MOLECULAR INC. |
| 15 | 00884999048898 | 09N19-012 | 09N19-012 | Alinity m | ABBOTT MOLECULAR INC. | |
| 16 | 00884999048171 | 09N26-020 | 09N26-020 | Alinity m IRU Waste Container | Alinity m | ABBOTT MOLECULAR INC. |
| 17 | 00884999048096 | 09N26-019 | 09N26-019 | Alinity m Sample Rack Holder | Alinity m | ABBOTT MOLECULAR INC. |
| 18 | 00884999048034 | 08N53-002 | 08N53-002 | Alinity m System | Alinity m | ABBOTT MOLECULAR INC. |
| 19 | 00884999047907 | 09N20-003 | 09N20-003 | Alinity m Diluent Solution Kit | Alinity m | ABBOTT MOLECULAR INC. |
| 20 | 00884999047884 | 09N50-001 | 09N50-001 | Alinity m Specimen Dilution Kit I | Alinity m | ABBOTT MOLECULAR INC. |
| 21 | 00884999047877 | 09N20-001 | 09N20-001 | Alinity m Lysis Solution | Alinity m | ABBOTT MOLECULAR INC. |
| 22 | 00884999047860 | 09N26-010 | 09N26-010 | Alinity m Integrated Reaction Unit (IRU) | Alinity m | ABBOTT MOLECULAR INC. |
| 23 | 00884999047853 | 09N26-002 | 09N26-002 | Alinity m Pipette Tips, 1000uL | Alinity m | ABBOTT MOLECULAR INC. |
| 24 | 00884999047846 | 09N26-001 | 09N26-001 | Allinity m Pipette Tips, 50uL | Alinity m | ABBOTT MOLECULAR INC. |
| 25 | 00884999047716 | 09N20-004 | 09N20-004 | Alinity m Vapor Barrier Solution | Alinity m | ABBOTT MOLECULAR INC. |
| 26 | 00884999047693 | 09N20-002 | 09N20-002 | Alinity m Ethanol Solution | Alinity m | ABBOTT MOLECULAR INC. |
| 27 | 00884999047686 | 09N18-001 | 09N18-001 | Alinity m Sample Prep Kit 1 | Alinity m | ABBOTT MOLECULAR INC. |
| 28 | 00884999047679 | 09N12-001 | 09N12-001 | Alinity m Sample Prep Kit 2 | Alinity m | ABBOTT MOLECULAR INC. |
| 29 | 00884999047501 | 09N26-004 | 09N26-004 | Alinity m CO-RE Tip Sleeve | Alinity m | ABBOTT MOLECULAR INC. |
| 30 | 00884999047488 | 09N26-003 | 09N26-003 | Alinity m Pipette Tip Adapters | Alinity m | ABBOTT MOLECULAR INC. |
| 31 | 00884999047464 | 09N26-016 | 09N26-016 | Alinity m Universal Sample Rack | Alinity m | ABBOTT MOLECULAR INC. |
| 32 | 00884999047457 | 09N26-015 | 09N26-015 | Alinity m Handheld Barcode Scanner | Alinity m | ABBOTT MOLECULAR INC. |
| 33 | 00884999047440 | 09N26-014 | 09N26-014 | Alinity m Assay Tray Carrier | Alinity m | ABBOTT MOLECULAR INC. |
| 34 | 00884999047433 | 09N26-013 | 09N26-013 | Alinity m Waste Bottle | Alinity m | ABBOTT MOLECULAR INC. |
| 35 | 00884999047426 | 09N26-012 | 09N26-012 | Alinity m Waste Box | Alinity m | ABBOTT MOLECULAR INC. |
| 36 | 00884999043503 | 08N89-001 | 08N89-001 | m2000rt SYSTEM SOFTWARE Release 8.0 | m2000 | ABBOTT MOLECULAR INC. |
| 37 | 00884999043497 | 08N88-001 | 08N88-001 | m2000sp SYSTEM SOFTWARE, Release 8.0 | m2000 | ABBOTT MOLECULAR INC. |
| 38 | 00884999032064 | 9K32-01 | 9K32-01 | Adhesive Cover Applicator | m2000 | ABBOTT MOLECULAR INC. |
| 39 | 00884999032057 | 9K31-01 | 9K31-01 | Splash Free Support Base | m2000 | ABBOTT MOLECULAR INC. |
| 40 | 00884999031814 | 9K15-01 | 9K15-01 | m2000rt Instrument System | m2000 | ABBOTT MOLECULAR INC. |
| 41 | 00884999006577 | 04J71-93 | 04J71-93 | Abbott m2000rt Optical Calibration Kit | m2000 | ABBOTT MOLECULAR INC. |
| 42 | 00884999006539 | 4J71-75 | 4J71-75 | Optical Adhesive Cover | m2000 | ABBOTT MOLECULAR INC. |
| 43 | 00884999006522 | 4J71-70 | 4J71-70 | 96-Well Optical Reaction Plate | m2000 | ABBOTT MOLECULAR INC. |
| 44 | 00875197005950 | 08160104190 | 08160104190 | cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
| 45 | 00875197005783 | 07460082190 | 07460082190 | cobas CTNG Positive Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
| 46 | 00875197005776 | 07460066190 | 07460066190 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | ROCHE MOLECULAR SYSTEMS, INC. | |
| 47 | 00875197005738 | 07958021190 | 07958021190 | cobas PCR Media Dual Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
| 48 | 00875197005721 | 07958030190 | 07958030190 | cobas® PCR Media Uni Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
| 49 | 00875197005660 | 07402759190 | 07402759190 | cobas Liat Cleaning Tool | ROCHE MOLECULAR SYSTEMS, INC. | |
| 50 | 00875197005653 | 07402686190 | 07402686190 | cobas® Influenza A/B &RSV Quality Control Kit for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. |