antylia.com
zeptometrix.comNATtrol BD MAX Vaginal Panel External Controls
Zeptometrix
Zeptometrix
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3000202849 | 3000202849 | ZEPTOMETRIX LLC | 1 | N | 2026-01-01 | 25 Kenwood Circle Franklin MA US 02038 |
| 3012101172 | 1318994 | ZEPTOMETRIX LLC. | 1 | N | 2026-01-01 | 878 Main Street Buffalo NY US 14202 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 01220000260450 | 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. | 1-800-274-5487 | diagnostic.cs@zeptometrix.com |
| 01220000260467 | 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. | 1-800-274-5487 | diagnostic.cs@zeptometrix.com |
| 01220000260481 | 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. | 1-800-274-5487 | zepto.customerservice@antylia.com |
| 01220000260498 | 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. | 1-800-274-5487 | zepto.customerservice@antylia.com |
| 01220000260542 | 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. | 800-274-5487 | zepto.customerservice@antylia.com |
Registered Device Listings#
| Registration key | Listing key |
|---|---|
| 229310 | 1380623240 |
| 229310 | 1448413698 |
| 187566 | 1380623240 |
| 187566 | 1448413698 |
| 187566 | 1816724432 |
PMN#
GUDID#
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.
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.
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.
2025-12-01
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.
2025-09-10
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.
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.
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.
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.
2025-07-23
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.
2022-03-31
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.
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.
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.
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.
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.
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.
2023-12-15
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.
2023-11-13
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.
2023-11-13
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.
2024-07-22
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.
2024-07-22
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.
2024-06-28
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.
2024-06-28
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.
2022-11-03
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.
2022-11-03
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.
2023-03-08
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.
2023-03-08
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.
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.
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.
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.
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.
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.
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.
2022-09-02
NATtrol™ - 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.
2020-10-16
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.
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.
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.
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.
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.
2020-10-15
NATtrol™ - 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.
2020-10-15
NATtrol™ - 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.
2020-10-16