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 | 05415219000126 | Idylla™ Console | P1010 | The Idylla™ Console is a computer with a vertically oriented touch-screen and a The Idylla™ Console is a computer with a vertically oriented touch-screen and a barcode reader placed directly below the touch-screen that communicates with the Idylla™ Instruments. Idylla™ Console and up to eight Idylla™ Instruments constitute the Idylla™ System. | Idylla™ System | BIOCARTIS NV |
2 | 05415219000119 | Idylla™ Instrument | P0010 | Up to eight Idylla™ Instruments and the Idylla™ Console constitute the Idylla™ System. | Idylla™ System | BIOCARTIS NV |
3 | 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 |
4 | 04053228033905 | V1 | 691221 | QIAstat-Dx® Respiratory Panel | QIAGEN GMBH | |
5 | 04053228010838 | 1 | 9002035 | Rotor-Gene® Q MDx | QIAGEN GMBH | |
6 | 04053228010746 | 1 | 9001301 | QIAsymphony AS | QIAGEN GMBH | |
7 | 04015630929016 | 05200881001 | 05200881001 | cobas z 480 | ROCHE MOLECULAR SYSTEMS, INC. | |
8 | 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 |
9 | 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 |
10 | 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 | |
11 | 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 |
12 | 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 |
13 | 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 |
14 | 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. |
15 | 00884999049314 | 09N20-012 | 09N20-012 | Alinity m Bottle for Ethanol Use | Alinity m | ABBOTT MOLECULAR INC. |
16 | 00884999048898 | 09N19-012 | 09N19-012 | Alinity m | ABBOTT MOLECULAR INC. | |
17 | 00884999048171 | 09N26-020 | 09N26-020 | Alinity m IRU Waste Container | Alinity m | ABBOTT MOLECULAR INC. |
18 | 00884999048096 | 09N26-019 | 09N26-019 | Alinity m Sample Rack Holder | Alinity m | ABBOTT MOLECULAR INC. |
19 | 00884999048034 | 08N53-002 | 08N53-002 | Alinity m System | Alinity m | ABBOTT MOLECULAR INC. |
20 | 00884999047907 | 09N20-003 | 09N20-003 | Alinity m Diluent Solution Kit | Alinity m | ABBOTT MOLECULAR INC. |
21 | 00884999047884 | 09N50-001 | 09N50-001 | Alinity m Specimen Dilution Kit I | Alinity m | ABBOTT MOLECULAR INC. |
22 | 00884999047877 | 09N20-001 | 09N20-001 | Alinity m Lysis Solution | Alinity m | ABBOTT MOLECULAR INC. |
23 | 00884999047860 | 09N26-010 | 09N26-010 | Alinity m Integrated Reaction Unit (IRU) | Alinity m | ABBOTT MOLECULAR INC. |
24 | 00884999047853 | 09N26-002 | 09N26-002 | Alinity m Pipette Tips, 1000uL | Alinity m | ABBOTT MOLECULAR INC. |
25 | 00884999047846 | 09N26-001 | 09N26-001 | Allinity m Pipette Tips, 50uL | Alinity m | ABBOTT MOLECULAR INC. |
26 | 00884999047716 | 09N20-004 | 09N20-004 | Alinity m Vapor Barrier Solution | Alinity m | ABBOTT MOLECULAR INC. |
27 | 00884999047693 | 09N20-002 | 09N20-002 | Alinity m Ethanol Solution | Alinity m | ABBOTT MOLECULAR INC. |
28 | 00884999047686 | 09N18-001 | 09N18-001 | Alinity m Sample Prep Kit 1 | Alinity m | ABBOTT MOLECULAR INC. |
29 | 00884999047679 | 09N12-001 | 09N12-001 | Alinity m Sample Prep Kit 2 | Alinity m | ABBOTT MOLECULAR INC. |
30 | 00884999047501 | 09N26-004 | 09N26-004 | Alinity m CO-RE Tip Sleeve | Alinity m | ABBOTT MOLECULAR INC. |
31 | 00884999047488 | 09N26-003 | 09N26-003 | Alinity m Pipette Tip Adapters | Alinity m | ABBOTT MOLECULAR INC. |
32 | 00884999047464 | 09N26-016 | 09N26-016 | Alinity m Universal Sample Rack | Alinity m | ABBOTT MOLECULAR INC. |
33 | 00884999047457 | 09N26-015 | 09N26-015 | Alinity m Handheld Barcode Scanner | Alinity m | ABBOTT MOLECULAR INC. |
34 | 00884999047440 | 09N26-014 | 09N26-014 | Alinity m Assay Tray Carrier | Alinity m | ABBOTT MOLECULAR INC. |
35 | 00884999047433 | 09N26-013 | 09N26-013 | Alinity m Waste Bottle | Alinity m | ABBOTT MOLECULAR INC. |
36 | 00884999047426 | 09N26-012 | 09N26-012 | Alinity m Waste Box | Alinity m | ABBOTT MOLECULAR INC. |
37 | 00884999043503 | 08N89-001 | 08N89-001 | m2000rt SYSTEM SOFTWARE Release 8.0 | m2000 | ABBOTT MOLECULAR INC. |
38 | 00884999043497 | 08N88-001 | 08N88-001 | m2000sp SYSTEM SOFTWARE, Release 8.0 | m2000 | ABBOTT MOLECULAR INC. |
39 | 00884999032064 | 9K32-01 | 9K32-01 | Adhesive Cover Applicator | m2000 | ABBOTT MOLECULAR INC. |
40 | 00884999032057 | 9K31-01 | 9K31-01 | Splash Free Support Base | m2000 | ABBOTT MOLECULAR INC. |
41 | 00884999031814 | 9K15-01 | 9K15-01 | m2000rt Instrument System | m2000 | ABBOTT MOLECULAR INC. |
42 | 00884999006577 | 04J71-93 | 04J71-93 | Abbott m2000rt Optical Calibration Kit | m2000 | ABBOTT MOLECULAR INC. |
43 | 00884999006539 | 4J71-75 | 4J71-75 | Optical Adhesive Cover | m2000 | ABBOTT MOLECULAR INC. |
44 | 00884999006522 | 4J71-70 | 4J71-70 | 96-Well Optical Reaction Plate | m2000 | ABBOTT MOLECULAR INC. |
45 | 00875197005950 | 08160104190 | 08160104190 | cobas® Influenza A/B & RSV Nucleic acid test for use on the cobas® Liat® System | ROCHE MOLECULAR SYSTEMS, INC. | |
46 | 00875197005783 | 07460082190 | 07460082190 | cobas CTNG Positive Control Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
47 | 00875197005776 | 07460066190 | 07460066190 | cobas CTNG Qualitative nucleic acid test for use on the cobas 6800/8800 Systems | ROCHE MOLECULAR SYSTEMS, INC. | |
48 | 00875197005738 | 07958021190 | 07958021190 | cobas PCR Media Dual Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
49 | 00875197005721 | 07958030190 | 07958030190 | cobas® PCR Media Uni Swab Sample Kit | ROCHE MOLECULAR SYSTEMS, INC. | |
50 | 00875197005660 | 07402759190 | 07402759190 | cobas Liat Cleaning Tool | ROCHE MOLECULAR SYSTEMS, INC. |