ZEPTOMETRIX LLC

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GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

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Registered Device Listings#

PMN#

• NATtrol BD MAX Vaginal Panel External Controls

  2022-02-02

  Zeptometrix

GUDID#

• NATtrol™ - NATtrol™ Respiratory Bundle (NATRSP-BU1-IVD) contains qualitative in vitro diagnostic positive and negative external controls intended to evaluate test performance of molecular assays which detect nucleic acids from Adenovirus, Bordetella pertussis, Bordetella parapertussis, Chlamydia pneumoniae, Coronavirus, Human Metapneumovirus, Influenza A, Influenza B, Mycoplasma pneumoniae, Parainfluenza, Rhino-Enterovirus, RSV and SARS-CoV-2.

  ZEPTOMETRIX CORPORATION

  2026-06-04

• NATtrol™ - NATtrol™ Respiratory Negative Control (NATRSPNEG-8C-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect nucleic acids from Adenovirus, Bordetella pertussis, Bordetella parapertussis, Chlamydia pneumoniae, Coronavirus, Human Metapneumovirus, Influenza A, Influenza B, Mycoplasma pneumoniae, Parainfluenza, Rhino-Enterovirus, RSV and SARS-CoV-2.

  ZEPTOMETRIX CORPORATION

  2026-06-04

• NATtrol™ - NATtrol™ Respiratory Positive Control (NATRSPPOS-8C-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect nucleic acids from Adenovirus, Bordetella pertussis, Bordetella parapertussis, Chlamydia pneumoniae, Coronavirus, Human Metapneumovirus 8, Influenza A, Influenza B, Mycoplasma pneumoniae, Parainfluenza Type 1, Parainfluenza Type 2, Parainfluenza Type 3, Parainfluenza Type 4, Rhinovirus Type 1A, RSV A, RSV B, and SARS-CoV-2.

  ZEPTOMETRIX CORPORATION

  2026-06-04

• NATtrol™ - NATtrol™ Respiratory/Sore Throat (R/ST) Control Kit (NATRSTK-BIO-IVD) is a qualitative in vitro diagnostic external control kit containing positive and negative controls intended to evaluate test performance of molecular assays which detect nucleic acids from Adenovirus, Bordetella parapertussis, Bordetella pertussis, Chlamydia pneumoniae, Coronavirus SARS-CoV-2, Human metapneumovirus, Human rhinovirus/enterovirus, Influenza A virus, Influenza A virus A/H1-2009, Influenza A virus A/H3, Influenza B virus, Mycoplasma pneumoniae, Parainfluenza virus, Respiratory syncytial virus, Streptococcus. dysgalactiae, and Streptococcus pyogenes.

  ZEPTOMETRIX CORPORATION

  2026-03-25

• NATtrol™ - NATtrol™ CT/NG/TV External Run Control Kit are qualitative positive and negative external run controls intended to be used with molecular assays for the detection of C. trachomatis, N. gonorrhoeae, and T. vaginalis DNA for the evaluation of test performance.

  ZEPTOMETRIX CORPORATION

  2025-03-06

• NATtrol™ - NATtrol™ Flu/RSV/SARS-CoV-2 Swab Control Kit NATFRC-SW-IVD) is a qualitative in vitro diagnostic external control kit containing positive and negative controls intended to evaluate test performance of molecular assays which detect Influenza A, Influenza B, RSV B and SARS-CoV-2 nucleic acids.

  ZEPTOMETRIX CORPORATION

  2025-12-01

• NATtrol™ - NATtrol™ Strep A Negative Control (NATSDG-6MC-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Streptococcus pyogenes nucleic acids.

  ZEPTOMETRIX CORPORATION

  2025-09-10

• NATtrol™ - NATtrol™ Strep A Positive Control (NATSPY-6MC-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Streptococcus pyogenes nucleic acids.

  ZEPTOMETRIX CORPORATION

  2025-09-10

• NATtrol™ - NATtrol™ Hepatitis C Virus Bundle (NATHCV-BU1-IVD) contains qualitative in vitro diagnostic positive and negative external controls intended to evaluate test performance of molecular assays which detect Hepatitis C virus nucleic acids.

  ZEPTOMETRIX CORPORATION

  2025-08-06

• NATtrol™ - NATtrol™ GI Controls (NATGIC-BIO-IVD) are qualitative in vitro diagnostic external controls intended to evaluate test performance of molecular assays which detect nucleic acids from Adenovirus Type 41, C. difficile, C. parvum, E. coli (92.0147; EAEC1), E. coli (EDL933; O157), P. shigelloides, Rotavirus,S. sonnei, Sapovirus ( S. cerevisiae recombinant), V. cholera non-toxigenic, Y. enterocolitica, Astrovirus (S. cerevisiae recombinant),C. cayetanensis (S. cerevisiae recombinant), C. coli, C. jejuni, E. coli (7.1493; O84:H28; EPEC1),E. coli (ETEC; ST+, LT+), E. histolytica,G. lamblia,Norovirus GI (recombinant), Norovirus GII (recombinant),S. enterica typhimurium.

  ZEPTOMETRIX CORPORATION

  2025-07-25

• NATtrol™ - NATtrol™ Meningitis/Encephalitis (ME) Controls (NATMEC-BIO-IVD) are qualitative in vitro diagnostic external controls intended to evaluate test performance of molecular assays which detect nucleic acids from Cytomegalovirus, E. coli, Echovirus Type 11, HHV-6B, S. pneumoniae, C. gattii, HSV-1, N. meningitidis serogroup A, S. agalactiae,H. influenzae, HSV-2, L. monocytogenes serotype 1/2b, Parechovirus Type 3, VZV.

  ZEPTOMETRIX CORPORATION

  2025-07-23

• NATtrol™ - 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.

  ZEPTOMETRIX CORPORATION

  2022-03-31

• NATtrol™ - 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.

  ZEPTOMETRIX CORPORATION

  2022-03-31

• NATtrol™ - 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.

  ZEPTOMETRIX CORPORATION

  2022-03-31

• NATtrol™ - NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for BD MAX™ System. NATtrol Candida/TV Positive Control is a qualitative control containing intact and inactivated Candida albicans, Candida krusei, Candida glabrata, and Trichomonas vaginalis and intended to be used solely with the BD Vaginal Panel for the BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

  ZEPTOMETRIX CORPORATION

  2022-03-31

• NATtrol™ - NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol BV Negative Control is a qualitative control containing intact and inactivated Lactobacillus crispatus and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

  ZEPTOMETRIX CORPORATION

  2022-03-31

• NATtrol™ - NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control material to monitor the performance of in vitro diagnostic laboratory nucleic acid testing procedures for the qualitative detection of targets on the BD Vaginal Panel for the BD MAX™ System. NATtrol™ BV Positive Control is a qualitative control containing intact and inactivated Lactobacillus jensenii, Gardnerella vaginalis, Atopobium vaginae, and Saccharomyces cerevisiae containing BVAB2 (Bacterial Vaginosis-Associated Bacterium 2) sequence and intended to be used solely with the BD Vaginal Panel for BD MAX™ System. This product is not intended to replace manufacturer controls provided in the package insert.

  ZEPTOMETRIX CORPORATION

  2022-03-31

• NATtrol™ - NATtrol™ Vaginal Mini Bundle is a packaging configuration that contains qualitative in vitro diagnostic controls, NATtrol Vaginal Positive Control (NATVPOS-6C) and NATtrol Vaginal Negative Control (NATVNEG-6C), 1 each, 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.

  ZEPTOMETRIX CORPORATION

  2023-12-15

• NATtrol™ - NATtrol™ Mpox Virus Negative Control (NATMPXVNEG-6C-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Mpox virus nucleic acids.

  ZEPTOMETRIX CORPORATION

  2023-11-13

• NATtrol™ - NATtrol™ Mpox Virus Positive Control (NATMPXVPOS-6C-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Mpox virus nucleic acids.

  ZEPTOMETRIX CORPORATION

  2023-11-13

• NATtrol™ - NATtrol™ HCV Virus Negative Control (NATHCVNEG-6C-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Hepatitis C virus nucleic acids.

  ZEPTOMETRIX CORPORATION

  2024-07-22

• NATtrol™ - NATtrol™ HCV Virus Positive Control (NATHCV-6C-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Hepatitis C virus nucleic acids.

  ZEPTOMETRIX CORPORATION

  2024-07-22

• NATtrol™ - NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control Swabs (NATFRCNEG-SW-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Influenza A, Influenza B, RSV B and SARS-CoV-2 nucleic acids.

  ZEPTOMETRIX CORPORATION

  2024-06-28

• NATtrol™ - NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control Swab (NATFRC-SW-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Influenza A, Influenza B, RSV B and SARS-CoV-2 nucleic acids.

  ZEPTOMETRIX CORPORATION

  2024-06-28

• NATtrol™ - The NATtrol™ Flu/RSV/SARS-CoV-2 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™ Flu/RSV/SARS-CoV-2 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.

  ZEPTOMETRIX CORPORATION

  2022-11-03

• NATtrol™ - The NATtrol™ Flu/RSV/SARS-CoV-2 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™ Flu/RSV/SARS-CoV-2 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.

  ZEPTOMETRIX CORPORATION

  2022-11-03

• NATtrol™ - NATtrol™ CT/NG/TV Negative Control is a qualitative external run control intended to be used with molecular assays for the detection of C. trachomatis, N. gonorrhoeae, and T. vaginalis DNA for the evaluation of test performance.

  ZEPTOMETRIX CORPORATION

  2023-03-08

• NATtrol™ - NATtrol™ CT/NG/TV Positive Control is a qualitative external run control intended to be used with molecular assays for the detection of C. trachomatis, N. gonorrhoeae, and T. vaginalis DNA for the evaluation of test performance.

  ZEPTOMETRIX CORPORATION

  2023-03-08

• NATtrol™ - The NATtrol™ SARS-Related Coronavirus 2 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™ SARS-Related Coronavirus 2 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.

  ZEPTOMETRIX CORPORATION

  2022-11-03

• NATtrol™ - The NATtrol™ SARS-Related Coronavirus 2 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™ SARS-Related Coronavirus 2 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.

  ZEPTOMETRIX CORPORATION

  2022-11-03

• NATtrol™ - The NATtrol™ SARS-Related Coronavirus 2 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™ SARS-Related Coronavirus 2 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.

  ZEPTOMETRIX CORPORATION

  2022-11-03

• NATtrol™ - The NATtrol™ SARS-Related Coronavirus 2 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™ SARS-Related Coronavirus 2 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.

  ZEPTOMETRIX CORPORATION

  2022-11-03

• NATtrol™ - The NATtrol™ Trichomonas vaginalis (T. vaginalis) 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™ T. vaginalis 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.

  ZEPTOMETRIX CORPORATION

  2022-09-02

• NATtrol™ - The NATtrol™ Trichomonas vaginalis (T. vaginalis) 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™ T. vaginalis 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.

  ZEPTOMETRIX CORPORATION

  2022-09-02

• NATtrol™ - 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.

  ZEPTOMETRIX CORPORATION

  2022-09-02

• NATtrol™ - 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.

  ZEPTOMETRIX CORPORATION

  2020-10-15

• NATtrol™ - 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.

  ZEPTOMETRIX CORPORATION

  2020-10-15

• NATtrol™ - 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.

  ZEPTOMETRIX CORPORATION

  2020-10-15

• NATtrol™ - 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.

  ZEPTOMETRIX CORPORATION

  2020-10-15

• NATtrol™ - 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.

  ZEPTOMETRIX CORPORATION

  2020-10-15

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