FDA.reportPublic FDA data

ZEPTOMETRIX LLC

Matched from indexed company URL: ZEPTOMETRIX LLC.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30002028493000202849ZEPTOMETRIX LLC1N2026-01-0125 Kenwood Circle Franklin MA US 02038
30121011721318994ZEPTOMETRIX LLC.1N2026-01-01878 Main Street Buffalo NY US 14202

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
01220000260450NATtrol™ - 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.1-800-274-5487diagnostic.cs@zeptometrix.com
01220000260467NATtrol™ - 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.1-800-274-5487diagnostic.cs@zeptometrix.com
01220000260542NATtrol™ - 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.800-274-5487zepto.customerservice@antylia.com
01220000260597NATtrol™ - 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-2.800-274-5487zepto.customerservice@antylia.com
01220000260603NATtrol™ - 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-2.800-274-5487zepto.customerservice@antylia.com
01220000260610NATtrol™ - 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-2.800-274-5487diagnostic.cs@zeptometrix.com
01220000260634NATtrol™ - 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.800-274-5487zepto.customerservice@antylia.com
01220000260641NATtrol™ - 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.800-274-5487zepto.customerservice@antylia.com

Registered Device Listings#

Registration key, Listing key table
Registration keyListing key
2293101380623240
2293101448413698
1875661380623240
1875661448413698
1875661816724432

PMN#

GUDID#

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™ 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™ 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™ - 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™ - 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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