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No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00850212007072 2130162 Fertility Control
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3 00850212007027 1633 220 test kit GMT Antigens, Ha, Treponema Pallidum 2 Serodia TP-PA
4 00850212007010 1626 100 test kit GMT Antigens, Ha, Treponema Pallidum 2 Serodia TP-PA
5 00850212007096 4008248 Lumipulse G Wash Solution JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1 Lumipulse G Wash Solution
6 00850212007089 2130166 JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Vitamin D Control
7 00850212007034 2130152 JJX Single (Specified) Analyte Controls (Assayed And Unassayed) 1 Vitamin D Control
8 00850212007041 PH3502 KSZ System, Test, Automated Blood Grouping And Antibody 2 Beckman Coulter PK TP System Control Set
9 00850212007003 800-092 GOI Antiserum, Fluorescent, Rabies Virus 2 FITC Anti-Rabies Monoclonal Globulin
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No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
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14 00812242030888 COV019CE COV019CE SARS-CoV-2 Positive Run Control Exact Diagnostics EXACT DIAGNOSTICS, LLC
15 00812242030857 RPNEG RPNEG RP Negative Run Control Exact Diagnostics EXACT DIAGNOSTICS, LLC
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17 00812242030802 ERLRC ERLRC Ehrlichia Run Control Exact Diagnostics EXACT DIAGNOSTICS, LLC
18 00812242030796 BORRC BORRC Borrelia Run Control Exact Diagnostics EXACT DIAGNOSTICS, LLC
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20 00812242030772 BABRC BABRC Babesia Run Control Exact Diagnostics EXACT DIAGNOSTICS, LLC
21 00812242030765 ANARC ANARC Anaplasma Run Control Exact Diagnostics EXACT DIAGNOSTICS, LLC
22 00812242030758 RPRC RPRC Respiratory Run Control Exact Diagnostics EXACT DIAGNOSTICS, LLC
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27 00812242030703 HBVLOD HBVLOD HBV LOD Exact Diagnostics EXACT DIAGNOSTICS, LLC
28 00812242030666 HCVLOD HCVLOD HCV LOD Exact Diagnostics EXACT DIAGNOSTICS, LLC
29 00812242030628 CMVLOD CMVLOD CMV LOD Exact Diagnostics EXACT DIAGNOSTICS, LLC
30 00812242030581 HIVLOD HIVLOD HIV-1 LOD Exact Diagnostics EXACT DIAGNOSTICS, LLC
31 00812242030543 JCVH102 JCVH102 JCV High Run Control Exact Diagnostics EXACT DIAGNOSTICS, LLC
32 00812242030536 JCVL101 JCVL101 JCV Low Run Control Exact Diagnostics EXACT DIAGNOSTICS, LLC
33 00812242030512 CTNGRC CTNGRC CT/NG Run Control Exact Diagnostics EXACT DIAGNOSTICS, LLC
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