Other products from "BIO-RAD LABORATORIES, INC."
No Primary DI Version or Model Catalog Number Device Description Product Code Product Code Name Device Class Brand Name
1 00847865000758 6632440 6632440 MMRV IgG Control Lot Data OPL,LJY,LFY,LJB Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zost Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus,ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER,Enzyme linked immunoabsorbent assay, rubeola IgG 1 BioPlex 2200
2 00847865000437 6631640 6631640 ToRC IgG Control Lot Data JJY Multi-analyte controls, all kinds (assayed) 1 BioPlex 2200
3 00847865013017 SW4.1V1 6652365A Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1 MVM,MST Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin 2 BioPlex 2200
4 00847865013000 SW4.1V1 6652365A Manual & CDs, Celiac IgA and IgG IFU, SW4.1_v1 MVM,MST Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin 2 BioPlex 2200
5 00847865012997 SW4.1_1 6652165B Manual & CDs, APLS IgA IFU, SW4.1_v1, US Only MID,MSV SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) 2 BioPlex 2200
6 00847865012980 SW4.1V1 6652065B Manual & CDs, APLS IgM IFU, SW4.1_v1 MID,MSV SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycopro SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL,System,test,antibodies,b2 - glycoprotein i (b2 - gpi) 2 BioPlex 2200
7 00847865012973 SW4.1V1 6651975B APLS IgG, IgM and IgA Assay Protocol File CD, SW4.1_v1 US Only MSV,MID System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL 2 BioPlex 2200
8 00847865012966 SW4.1V1 6651965B Manual & CDs, APLS IgG IFU, SW4.1_v1, US Only MSV,MID System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL 2 BioPlex 2200
9 00847865012614 SW4.1_V1 6651260F Manual & CDs, EBV IgG IFU, SW4.1v1 LSE EPSTEIN-BARR VIRUS, OTHER 1 BioPlex 2200
10 00847865012607 SW4.1_V1 6651270D EBV IgG Assay Protocol File CD, SW4.1_v1, US LSE EPSTEIN-BARR VIRUS, OTHER 1 BioPlex 2200
11 00847865012577 SW4.1_V1 6653860D Manual & CDs, Rubella & CMV IgM IFU, SW4.1_v1, U.S Only LFX,LKQ,LFZ ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VI ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS 2 BioPlex 2200
12 00847865012522 SW4_1 6651965A Manual & CDs, BioPlex 2200 APLS IgG IFU, SW4_v1, US Only MSV,MID System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL 2 BioPlex 2200
13 00847865012515 SW4_1 6652065A Manual & CDs, APLS IgM IFU, SW4_v1, US Only MSV,MID System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL 2 BioPlex 2200
14 00847865012508 SW4_1 6651975A APLS IgG, IgM and IgA Assay Protocol File CD, SW4_v1 MSV,MID System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLI System,test,antibodies,b2 - glycoprotein i (b2 - gpi),SYSTEM, TEST, ANTICARDIOLIPIN IMMUNOLOGICAL 2 BioPlex 2200
15 00847865012331 SW4.1_V2 6651170D ANA Screen with MDSS Assay Protocol File CD, SW4.1_v2 LLL,LKJ,LJM,MQA,LKO,LRM EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL,ANTINUCLEAR ANTIBODY, ANTI EXTRACTABLE ANTINUCLEAR ANTIBODY, ANTIGEN AND CONTROL,ANTINUCLEAR ANTIBODY, ANTIGEN, CONTROL,ANTINUCLEAR ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROLS,ANTI-RIBOSOMAL P ANTIBODIES,ANTI-RNP ANTIBODY, ANTIGEN AND CONTROL,ANTI-DNA ANTIBODY (ENZYME-LABELED), ANTIGEN, CONTROL 2 BioPlex 2200
16 00847865011655 6653750 6653750 25-OH Vitamin D Reagent Pack MRG SYSTEM, TEST, VITAMIN D 2 BioPlex 2200
17 00847865011648 6633740 6633740 25-OH Vitamin D Control Lot Data JJX Single (specified) analyte controls (assayed and unassayed) 1 BioPlex 2200
18 00847865011631 6633730 6633730 25-OH Vitamin D Control Set JJX Single (specified) analyte controls (assayed and unassayed) 1 BioPlex 2200
19 00847865011624 6633720 6633720 25-OH Vitamin D Lot Data JIT CALIBRATOR, SECONDARY 2 BioPlex 2200
20 00847865011617 6633700 6633700 25-OH Vitamin D Calibrator Set JIT CALIBRATOR, SECONDARY 2 BioPlex 2200
21 00847865011358 SW4V2 6651360F Manual & CDs, EBV IgM IFU, SW4_v2 LJN,KTN ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS,SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS 1 BioPlex 2200
22 00847865011341 6651360G 6651360G Manual & CDs, EBV IgM IFU, SW4.1_v1 LJN,KTN ANTIBODY IGM, IF, EPSTEIN-BARR VIRUS,SYSTEM, TEST, INFECTIOUS MONONUCLEOSIS 1 BioPlex 2200
23 00847865011129 SW4_1 6652360A Manual & CDs, Celiac IgA and IgG IFU, SW4_v1 MST,MVM Antibodies, gliadin,Autoantibodies, endomysial(tissue transglutaminase) 2 BioPlex 2200
24 00847865011105 6600306 6600306 BioPlex® 2200 Manual Reagent Pack Piercer MZF Test, Hiv Detection 2 BioPlex® 2200
25 00847865011082 SW4.1V1 6651860H Manual & CDs, Vasculitis IFU, SW4.1_v1 MOB,MVJ TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, anti TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, antibodies to glomerular basement membrane (gbm) 2 BioPlex 2200
26 00847865011075 SW4.1_1 6651665E U.S. IFU, Manual & CDs, ToRC IgG IFU, SW4.1_v1 OMI Multiplex flow immunoassay, t.Gondii, rubella and cmv. 2 BioPlex 2200
27 00847865011006 SW4.1_V1 6653870D Rubella & CMV IgM Assay Protocol File CD, SW4.1_v1 LFX,LKQ,LFZ ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VI ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS 2 BioPlex 2200
28 00847865010993 SW4.1_V2 6653370E HSV-1 & HSV-2 Assay Protocol File CD, SW4.1_v2 MYF,MXJ Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2,Enzyme linked imm Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2,Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1 2 BioPlex 2200
29 00847865010986 SW4.1_V1 6653270E BioPlex 2200 Anti-CCP Assay Protocol File CD, SW4.1_v1 JIX,NHX,JJY CALIBRATOR, MULTI-ANALYTE MIXTURE,ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE CALIBRATOR, MULTI-ANALYTE MIXTURE,ANTIBODIES, ANTI-CYCLIC CITRULLINATED PEPTIDE (CCP),Multi-analyte controls, all kinds (assayed) 1 BioPlex 2200
30 00847865010979 SW4.1_V1 6652470D MMRV IgG Assay Protocol File CD, SW4.1_v1 LJY,LFY,OPL,LJB ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT A ENZYME LINKED IMMUNOABSORBENT ASSAY, MUMPS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, VARICELLA-ZOSTER,Multiplex immunoassay for measles virus, mumps virus, rubella and varicella zoster virus,Enzyme linked immunoabsorbent assay, rubeola IgG 1 BioPlex 2200
31 00847865010962 SW4.1v1 6652270B Celiac IgG Assay Protocol File CD, SW4.1_v1 MST,MVM Antibodies, gliadin,Autoantibodies, endomysial(tissue transglutaminase) 2 BioPlex 2200
32 00847865010955 SW4.1 V1 6651870E Vasculitis Assay Protocol File CD, SW4.1_v1 MOB,MVJ TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, anti TEST SYSTEM, ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES (ANCA),Devices, measure, antibodies to glomerular basement membrane (gbm) 2 BioPlex 2200
33 00847865010948 SW4.1_V1 6651670H ToRC IgG Assay Protocol File CD, SW4.1_v1 OMI Multiplex flow immunoassay, t.Gondii, rubella and cmv. 2 BioPlex 2200
34 00847865010924 SW4.1_v1 6651470E Syphilis IgG Assay Protocol File CD, SW4.1_v1 LIP ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM 2 BioPlex 2200
35 00847865010917 6632220 6632220 Celiac IgG Calibrator Lot Data JIX CALIBRATOR, MULTI-ANALYTE MIXTURE 2 BioPlex 2200
36 00847865010900 6632320 6632320 Celiac IgA Calibrator Lot Data JIX CALIBRATOR, MULTI-ANALYTE MIXTURE 2 BioPlex 2200
37 00847865010894 6632240 6632240 Celiac IgG Control Lot Data JJX Single (specified) analyte controls (assayed and unassayed) 1 BioPlex 2200
38 00847865010887 6632340 6632340 Celiac IgA Control Lot Data JJX Single (specified) analyte controls (assayed and unassayed) 1 BioPlex 2200
39 00847865010863 6652250 6652250 Celiac IgG Reagent Pack MVM,MST Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin 2 BioPlex 2200
40 00847865010856 6652350 6652350 Celiac IgA Reagent Pack MVM,MST Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin 2 BioPlex 2200
41 00847865010627 6632230 6632230 Celiac IgG Control Set JJX Single (specified) analyte controls (assayed and unassayed) 1 BioPlex 2200
42 00847865010610 6632330 6632330 Celiac IgA Control Set JJX Single (specified) analyte controls (assayed and unassayed) 1 BioPlex 2200
43 00847865010603 6632200 6632200 Celiac IgG Calibrator Set, JIX CALIBRATOR, MULTI-ANALYTE MIXTURE 2 BioPlex 2200
44 00847865010597 6632300 6632300 Celiac IgA Calibrator Set JIX CALIBRATOR, MULTI-ANALYTE MIXTURE 2 BioPlex 2200
45 00847865010580 SW4_v1 6652370A Celiac IgA Assay Protocol File CD, SW4_v1 MVM,MST Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin 2 BioPlex 2200
46 00847865010573 SW4_v1 6652270A Celiac IgG Assay Protocol file CD, SW4_v1 MVM,MST Autoantibodies, endomysial(tissue transglutaminase),Antibodies, gliadin 2 BioPlex 2200
47 00847865006682 SW4.1_V1 6651460F Manual & CDs, Syphilis IgG IFU, SW4.1_v1 LIP ENZYME LINKED IMMUNOABSORPTION ASSAY, TREPONEMA PALLIDUM 2 BioPlex 2200
48 00847865004725 SW4_V2 6653360E Manual & CDs, HSV-1 & HSV-2 IgG IFU, SW4_v2 MXJ,MYF Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1,Enzyme linked imm Enzyme linked immunosorbent assay, herpes simplex virus, hsv-1,Enzyme linked immunosorbent assay, herpes simplex virus, hsv-2 2 BioPlex 2200
49 00847865003186 SW4_ V3 6653870C Rubella & CMV Assay Protocol File CD, SW4_v3 LFZ,LKQ,LFX ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS,ANTIBODY IGM,IF, CYTOMEGALO ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS,ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA 2 BioPlex 2200
50 00847865003179 SW4_V3 6653860C Manual & CDs, Rubella & CMV IgM IFU, SW4_v3, US Only LKQ,LFX,LFZ ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBE ANTIBODY IGM,IF, CYTOMEGALOVIRUS VIRUS,ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA,ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS 2 BioPlex 2200
Other products with the same Product Code "OHQ"
No Primary DI Version or Model Catalog Number Device Description Brand Name Organization Name
1 03573026121631 30706 Automated test for use on the VIDAS® system to detect abnormal operation of the Automated test for use on the VIDAS® system to detect abnormal operation of the VIDAS and mini VIDAS instrument pipette mechanisms and optical systems. VIDAS® QCV BIOMERIEUX SA
2 01220000260313 NATtrol™ Vaginal Bundle NATV-BU1 NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtr NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtrol Vaginal Positive Control (NATVPOS-6C) DI number 01220000260290, and NATtrol Vaginal Negative Control (NATVNEG-6C) DI number 01220000260306, which are intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance. NATtrol™ ZEPTOMETRIX CORPORATION
3 01220000260306 NATtrol™ Vaginal Negative Control NATVNEG-6C NATtrol™ Vaginal Negative Control (NATVNEG-6C) is a qualitative in vitro diagnos NATtrol™ Vaginal Negative Control (NATVNEG-6C) is a qualitative in vitro diagnostic control intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance. NATtrol™ ZEPTOMETRIX CORPORATION
4 01220000260290 NATtrol™ Vaginal Positive Control NATVPOS-6C NATtrol™ Vaginal Positive Control (NATVPOS-6C) is a qualitative in vitro diagnos NATtrol™ Vaginal Positive Control (NATVPOS-6C) is a qualitative in vitro diagnostic control intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance. NATtrol™ ZEPTOMETRIX CORPORATION
5 01220000260283 NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control NATCTNGNEG-6MC NATCTNGNEG-6MC is a qualitative in vitro diagnostic external run control intende NATCTNGNEG-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays. NATtrol™ ZEPTOMETRIX CORPORATION
6 01220000260276 NATtrol™ Neisseria gonorrhoeae (NG) Positive Control NATNG-6MC NATNG-6MC is a qualitative in vitro diagnostic external run control intended to NATNG-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays. NATtrol™ ZEPTOMETRIX CORPORATION
7 01220000260269 NATtrol™ Chlamydia trachomatis (CT) Positive Control NATCT(434)-6MC NATCT(434)-6MC is a qualitative in vitro diagnostic external run control intende NATCT(434)-6MC is a qualitative in vitro diagnostic external run control intended to be used with molecular assays. NATtrol™ ZEPTOMETRIX CORPORATION
8 01220000260221 NATtrol™ Staphylococcus aureus Positive Control NATMSSA-6MC-IVD The NATtrol™ Staphylococcus aureus (SA) Positive Control is an unassayed in vitr The NATtrol™ Staphylococcus aureus (SA) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ SA Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
9 01220000260214 NATtrol™ Methicillin-Resistant Staphylococcus aureus/Staphylococcus aureus NATMSSE-6MC-IVD The Methicillin-Resistant Staphylococcus aureus/Staphylococcus aureus (MRSA/SA) The Methicillin-Resistant Staphylococcus aureus/Staphylococcus aureus (MRSA/SA) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ MRSA/SA Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
10 01220000260207 NATtrol™ Methicillin-Resistant Staphylococcus aureus Positive Control NATMRSA-6MC-IVD The NATtrol™ Methicillin-Resistant Staphylococcus aureus (MRSA) Positive Control The NATtrol™ Methicillin-Resistant Staphylococcus aureus (MRSA) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ MRSA Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
11 01220000260191 NATtrol™ Trichomonas vaginalis Negative Control NATTVNEG-6MC-IVD The NATtrol™ Trichomonas vaginalis (T. vaginalis) Negative Control is an unassay The NATtrol™ Trichomonas vaginalis (T. vaginalis) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ T. vaginalis Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
12 01220000260177 NATtrol™ Enterovirus Negative Control NATEVNEG-6MC-IVD The NATtrol™ Enterovirus (EV) Negative Control is an unassayed in vitro diagnost The NATtrol™ Enterovirus (EV) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ EV Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
13 01220000260160 NATtrol™ Enterovirus Positive Control NATEVPOS-6MC-IVD The NATtrol™ Enterovirus (EV) Positive Control is an unassayed in vitro diagnost The NATtrol™ Enterovirus (EV) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ EV Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
14 01220000260153 NATtrol™ Group B Streptococci Negative Control NATLAC-6MC-IVD The NATtrol™ Group B Streptococcus (GBS) Negative Control is an unassayed in vit The NATtrol™ Group B Streptococcus (GBS) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ GBS Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
15 01220000260146 NATtrol™ Group B Streptococci Positive Control NATSAG-6MC-IVD The NATtrol™ Group B Streptococcus (GBS) Positive Control is an unassayed in vit The NATtrol™ Group B Streptococcus (GBS) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ GBS Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
16 01220000260139 NATtrol™ Norovirus Negative Control NATROTA-6MC-IVD The NATtrol™ Norovirus Negative Control is an unassayed in vitro diagnostic exte The NATtrol™ Norovirus Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Norovirus Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
17 01220000260122 NATtrol™ Norovirus GII Positive Control NATNOVII-6MC-IVD The NATtrol™ Norovirus GII Positive Control is an unassayed in vitro diagnostic The NATtrol™ Norovirus GII Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Norovirus GII Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
18 01220000260115 NATtrol™ Norovirus GI Positive Control NATNOVI-6MC-IVD The NATtrol™ Norovirus GI Positive Control is an unassayed in vitro diagnostic e The NATtrol™ Norovirus GI Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Norovirus GI Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
19 01220000260108 NATtrol™ Norovirus GI/GII Positive Control NATNOV-6MC-IVD The NATtrol™ Norovirus GI/GII Positive Control is an unassayed in vitro diagnost The NATtrol™ Norovirus GI/GII Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Norovirus GI/GII Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
20 01220000260092 NATtrol™ RSV Positive Control NATRSV-6C-IVD The NATtrol™ RSV Positive Control is an unassayed in vitro diagnostic external r The NATtrol™ RSV Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ RSV Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
21 01220000260085 NATtrol™ Influenza A/B Positive Control NATFLUAB-6C-IVD The NATtrol™ Influenza A/B Positive Control is an unassayed in vitro diagnostic The NATtrol™ Influenza A/B Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Influenza A/B Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
22 01220000260078 NATtrol™ Influenza/RSV Negative Control NATCXVA9-6C-IVD The NATtrol™ Influenza/RSV Negative Control is an unassayed in vitro diagnostic The NATtrol™ Influenza/RSV Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Influenza/RSV Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
23 01220000260061 NATtrol™ Clostridium difficile Negative Control NATCSO-6MC-IVD The NATtrol™ Clostridium difficile Negative Control is an unassayed in vitro dia The NATtrol™ Clostridium difficile Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Clostridium difficile Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
24 01220000260054 NATtrol™ Clostridium difficile Positive Control NATCDI-6MC-IVD The NATtrol™ Clostridium difficile Positive Control is an unassayed in vitro dia The NATtrol™ Clostridium difficile Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Clostridium difficile Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
25 01220000260047 NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae Negative Controls NATCT/NGNEG-6MC-IVD The NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Contro The NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from these organisms. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ CT/NG Negative Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
26 01220000260030 NATtrol™ Neisseria gonorrhoeae Positive Controls NATNG-6MC-IVD The NATtrol™ Neisseria gonorrhoeae (NG) Positive Control is an unassayed in vitr The NATtrol™ Neisseria gonorrhoeae (NG) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Neisseria gonorrhoeae Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
27 01220000260023 NATtrol™ Chlamydia trachomatis Positive Controls NATCT(434)-6MC-IVD NATtrol™ Chlamydia trachomatis (CT) Positive Control is an unassayed in vitro di NATtrol™ Chlamydia trachomatis (CT) Positive Control is an unassayed in vitro diagnostic external run control intended to be used with qualitative molecular assays for detection of nucleic acids from this organism. The control is intended to be used as an aid to diagnosis in that it is used to verify performance of the assays used to detect a physiological or pathological state. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic errors. NATtrol™ Chlamydia trachomatis (CT) Positive Control contains intact organisms and should be run in a manner identical to that used for clinical specimens. The control does not have an assigned value and it is the responsibility of the end user to establish their own target specifications for the control using their laboratory’s molecular procedures. NATtrol™ ZEPTOMETRIX CORPORATION
28 01220000260016 NATtrol™ RP Multimarker Controls MDZ001 NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic externa NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic external run controls intended for use with qualitative molecular assays. The routine and repetitive use of external run controls enables laboratories to monitor daily test variation, lot-to-lot test kit performance, individual operator variation, and can provide assistance in identifying increases in random or systemic error. NATtrol™ RP Multimarker Controls contain intact organisms and should be run in a manner identical to that used for clinical specimens.NATtrol™ RP Multimarker Controls are formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable. Each control pack contains 3 x 0.75 mL vials of RP Multimarker 1 and 3 x 0.75 mL vials of RP Multimarker 2. NATtrol™ RP Multimarker Controls are formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens. NATtrol™ ZEPTOMETRIX CORPORATION
29 EABA10090211 100-9021 100-9021 BRT Verification Samples are human liquid serum samples used to verify analyte l BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range. BRT Verification Samples with CRP BIORESOURCE TECHNOLOGY
30 EABA10090111 100-9011 100-9011 BRT Verification Samples are human liquid serum samples used to verify analyte l BRT Verification Samples are human liquid serum samples used to verify analyte linearity over the reportable range. BRT Verification Samples BIORESOURCE TECHNOLOGY
31 00884883007543 10027484 MAS Infectious Negative Control MICROGENICS CORPORATION
32 00884883007536 10027483 MAS Syphilis Positive Control MICROGENICS CORPORATION
33 00884883007529 10027482 MAS anti-HBs Positive Control MICROGENICS CORPORATION
34 00884883007512 10027481 MAS HIV p24 Positive Control MICROGENICS CORPORATION
35 00884883007505 10027480 MAS Omni Infectious BSI Positive Control Panel MICROGENICS CORPORATION
36 00884883007383 10027482-U MAS anti-HBs Positive Control – For use with Siemens Assays MICROGENICS CORPORATION
37 00884883007376 10027480-U MAS omni Infectious BSI Positive Control Panel for use with Siemens Assays MICROGENICS CORPORATION
38 00884883006935 960811 Acrometrix TriScreen MICROGENICS CORPORATION
39 00884883006645 969056 AcroMetrix Oncology Hotspot Control MICROGENICS CORPORATION
40 00884883006584 967151 Acrometrix Multi-Analyte Control HIV/HCV/HBV High MICROGENICS CORPORATION
41 00884883006577 967150 Acrometrix Multi-Analyte Control HIV/HCV/HBV Low MICROGENICS CORPORATION
42 00884883006560 967146 Acrometrix CT/NG Control MICROGENICS CORPORATION
43 00850212007065 2130170 Syphilis Control FUJIREBIO DIAGNOSTICS, INC.
44 00850004812501 20300002 20300002 ADULTER-SKREEN DOA Urine Validity Controls Adulter-Skreen BIOCHEMICAL DIAGNOSTICS INC
45 00847661005704 00142A 00142A VIROTROL HAV-IgM (An unassayed (human) serology control.) VIROTROL BIO-RAD LABORATORIES, INC.
46 00847661005575 00128B 00128B VIROTROL EBV (An unassayed (human) serology control.) VIROTROL BIO-RAD LABORATORIES, INC.
47 00847661005568 00128A 00128A VIROTROL EBV (An unassayed (human) serology control.) VIROTROL BIO-RAD LABORATORIES, INC.
48 00847661005476 00117B 00117B VIROTROL ToRCH-M (An unassayed (human) serology control.) VIROTROL BIO-RAD LABORATORIES, INC.
49 00847661005469 00171 00171 VIROTROL Syphilis LR-A (An unassayed (human) serology control.) VIROTROL BIO-RAD LABORATORIES, INC.
50 00847661005452 00172X 00172X VIROTROL Syphilis LR-B (An unassayed (human) serology control.) VIROTROL BIO-RAD LABORATORIES, INC.