No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
---|---|---|---|---|---|---|---|---|
1 | 00812242030345 | VZVP100 | VZVP100 | VZV Verification Panel | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
2 | 00812242030338 | ADVH102 | ADVH102 | Adenovirus High Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
3 | 00812242030321 | ADVL101 | ADVL101 | Adenovirus Low Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
4 | 00812242030055 | CMVH102 | CMVH102 | CMV High Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
5 | 00812242030048 | CMVL101 | CMVL101 | CMV Low Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
6 | 00812242030031 | CMVP100 | CMVP100 | CMV Verification Panel | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
7 | 00812242030604 | CMVL201 | CMVL201 | CMV 1E3 IU/mL Precision | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
8 | 00812242033766 | NEGSTI | NEGSTI | STI Negative Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
9 | 00812242033759 | CTNGPOS | CTNGPOS | CT/NG Positive Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
10 | 00812242031144 | NEGHAI | NEGHAI | HAI Negative Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
11 | 00812242031137 | NEGSYN | NEGSYN | Synthetic Negative Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
12 | 00812242031007 | HPVP200 | HPVP200 | HPV Verification Panel | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
13 | 00812242030901 | COVFLU | COVFLU | SARS-CoV-2, Flu, RSV Positive Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
14 | 00812242030895 | COV000CE | COV000CE | SARS-CoV-2 Negative Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
15 | 00812242030888 | COV019CE | COV019CE | SARS-CoV-2 Positive Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
16 | 00812242030857 | RPNEG | RPNEG | RP Negative Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
17 | 00812242030840 | RPPOS | RPPOS | RP Positive Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
18 | 00812242030802 | ERLRC | ERLRC | Ehrlichia Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
19 | 00812242030796 | BORRC | BORRC | Borrelia Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
20 | 00812242030789 | BRTRC | BRTRC | Bartonella Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
21 | 00812242030772 | BABRC | BABRC | Babesia Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
22 | 00812242030765 | ANARC | ANARC | Anaplasma Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
23 | 00812242030758 | RPRC | RPRC | Respiratory Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
24 | 00812242030741 | CTNGP200 | CTNGP200 | CT/NG Verification Panel | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
25 | 00812242030734 | CDFP200 | CDFP200 | C. difficile Verification Panel | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
26 | 00812242030727 | MRSAP200 | MRSAP200 | MRSA Verification Panel | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
27 | 00812242030710 | HSVP200 | HSVP200 | HSV Verification Panel | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
28 | 00812242030703 | HBVLOD | HBVLOD | HBV LOD | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
29 | 00812242030697 | HBVH202 | HBVH202 | HBV 1E6 IU/mL Precision | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
30 | 00812242030680 | HBVL201 | HBVL201 | HBV 1E3 IU/mL Precision | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
31 | 00812242030673 | HBVP200 | HBVP200 | HBV Verification Panel 1.4mL | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
32 | 00812242030666 | HCVLOD | HCVLOD | HCV LOD | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
33 | 00812242030659 | HCVH202 | HCVH202 | HCV 1E6 IU/mL Precision | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
34 | 00812242030642 | HCVL201 | HCVL201 | HCV 1E3 IU/mL Precision | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
35 | 00812242030635 | HCVP200 | HCVP200 | HCV Verification Panel 1.4mL | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
36 | 00812242030628 | CMVLOD | CMVLOD | CMV LOD | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
37 | 00812242030611 | CMVH202 | CMVH202 | CMV 5E5 IU/mL Precision | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
38 | 00812242030598 | CMVP200 | CMVP200 | CMV Verification Panel 1.4mL | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
39 | 00812242030581 | HIVLOD | HIVLOD | HIV-1 LOD | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
40 | 00812242030574 | HIVH202 | HIVH202 | HIV-1 1E5 cp/mL Precision | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
41 | 00812242030567 | HIVL201 | HIVL201 | HIV-1 1E3 cp/mL Precision | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
42 | 00812242030550 | HIVP200 | HIVP200 | HIV-1 Verification Panel 1.4mL | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
43 | 00812242030543 | JCVH102 | JCVH102 | JCV High Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
44 | 00812242030536 | JCVL101 | JCVL101 | JCV Low Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
45 | 00812242030529 | JCVP100 | JCVP100 | JCV Verification Panel | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
46 | 00812242030512 | CTNGRC | CTNGRC | CT/NG Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
47 | 00812242030505 | EVRC | EVRC | Enterovirus Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
48 | 00812242030499 | B19H102 | B19H102 | Parvovirus B19 High Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
49 | 00812242030482 | B19L101 | B19L101 | Parvovirus B19 Low Run Control | OHQ | Multi-Analyte Controls Unassayed | 1 | Exact Diagnostics |
50 | 00812242030475 | B19P100 | B19P100 | Parvovirus B19 Verification Panel | JIT | Calibrator, Secondary | 2 | Exact Diagnostics |
No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
---|---|---|---|---|---|---|
1 | 00840733103285 | 610220 | 610220 | The Revogene Check is a single-use, qualitative test utilizing automated real-ti The Revogene Check is a single-use, qualitative test utilizing automated real-time Polymerase Chain Reaction (PCR) to confirm that the optical and thermal parameters of the Revogene Instrument are within specifications. It is intended for use by qualified laboratory personnel who have been trained and are proficient in performing testing on the Revogene instrument or by Meridian Bioscience service personnel. | Revogene Check | MERIDIAN BIOSCIENCE, INC. |
2 | 00816784020338 | 2015-0076 | ACCURUN 121 HAV IgM 6 x 3.5 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. | |
3 | 00816784020321 | 2015-0074 | 2015-0074 | ACCURUN 121 HAV IgM 1 x 5.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
4 | 00816784020314 | 2015-0073 | 2015-0073 | ACCURUN 120 HAV IgG 1 x 5.0 mL | ACCURUN® | LGC CLINICAL DIAGNOSTICS, INC. |
5 | 00816387020452 | HGMPC1 | Histoplasma Galactomannan Positive Control | IMMY | IMMUNO-MYCOLOGICS, INC. | |
6 | 00816387020445 | HGMNC1 | Histoplasma Galactomannan Negative Control | IMMY | IMMUNO-MYCOLOGICS, INC. | |
7 | 00812242033766 | NEGSTI | NEGSTI | STI Negative Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
8 | 00812242033759 | CTNGPOS | CTNGPOS | CT/NG Positive Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
9 | 00812242031144 | NEGHAI | NEGHAI | HAI Negative Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
10 | 00812242031137 | NEGSYN | NEGSYN | Synthetic Negative Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
11 | 00812242031007 | HPVP200 | HPVP200 | HPV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
12 | 00812242030918 | COVFLUNEG | COVFLUNEG | SARS-CoV-2, Flu, RSV Negative Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
13 | 00812242030901 | COVFLU | COVFLU | SARS-CoV-2, Flu, RSV Positive Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
14 | 00812242030895 | COV000CE | COV000CE | SARS-CoV-2 Negative Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
15 | 00812242030888 | COV019CE | COV019CE | SARS-CoV-2 Positive Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
16 | 00812242030857 | RPNEG | RPNEG | RP Negative Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
17 | 00812242030840 | RPPOS | RPPOS | RP Positive Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
18 | 00812242030802 | ERLRC | ERLRC | Ehrlichia Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
19 | 00812242030796 | BORRC | BORRC | Borrelia Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
20 | 00812242030789 | BRTRC | BRTRC | Bartonella Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
21 | 00812242030772 | BABRC | BABRC | Babesia Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
22 | 00812242030765 | ANARC | ANARC | Anaplasma Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
23 | 00812242030758 | RPRC | RPRC | Respiratory Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
24 | 00812242030741 | CTNGP200 | CTNGP200 | CT/NG Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
25 | 00812242030734 | CDFP200 | CDFP200 | C. difficile Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
26 | 00812242030727 | MRSAP200 | MRSAP200 | MRSA Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
27 | 00812242030710 | HSVP200 | HSVP200 | HSV Verification Panel | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
28 | 00812242030703 | HBVLOD | HBVLOD | HBV LOD | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
29 | 00812242030666 | HCVLOD | HCVLOD | HCV LOD | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
30 | 00812242030628 | CMVLOD | CMVLOD | CMV LOD | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
31 | 00812242030581 | HIVLOD | HIVLOD | HIV-1 LOD | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
32 | 00812242030543 | JCVH102 | JCVH102 | JCV High Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
33 | 00812242030536 | JCVL101 | JCVL101 | JCV Low Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
34 | 00812242030512 | CTNGRC | CTNGRC | CT/NG Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
35 | 00812242030505 | EVRC | EVRC | Enterovirus Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
36 | 00812242030499 | B19H102 | B19H102 | Parvovirus B19 High Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
37 | 00812242030482 | B19L101 | B19L101 | Parvovirus B19 Low Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
38 | 00812242030468 | HSV2H102 | HSV2H102 | HSV-2 High Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
39 | 00812242030451 | HSV2L101 | HSV2L101 | HSV-2 Low Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
40 | 00812242030437 | HSV1H102 | HSV1H102 | HSV-1 High Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
41 | 00812242030420 | HSV1L101 | HSV1L101 | HSV-1 Low Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
42 | 00812242030406 | HV6H102 | HV6H102 | HHV-6 High Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
43 | 00812242030390 | HV6L101 | HV6L101 | HHV-6 Low Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
44 | 00812242030369 | VZVH102 | VZVH102 | VZV High Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
45 | 00812242030352 | VZVL101 | VZVL101 | VZV Low Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
46 | 00812242030338 | ADVH102 | ADVH102 | Adenovirus High Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
47 | 00812242030321 | ADVL101 | ADVL101 | Adenovirus Low Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
48 | 00812242030307 | ZKVH102 | ZKVH102 | Zika High Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
49 | 00812242030291 | ZKVL101 | ZKVL101 | Zika Low Run Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |
50 | 00812242030260 | HPVNEG | HPVNEG | HPV Negative Control | Exact Diagnostics | EXACT DIAGNOSTICS, LLC |