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…
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.
Who Else Makes It
Concentrated in Jilin (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Dirui Industrial Co., Ltd. | Changchun | Jilin | Contract manufacturer | 84 |
| Phase Scientific (Shenzhen) Company Limited | Shenzhen | Guangdong | Repacker / relabeller | 8 |
Record
| Listed by | Zeptometrix LLC., United States |
|---|---|
| FDA product code | OHQ |
| Device type | Multi-Analyte Controls Unassayed |
| Device class | Class 1 |
| Regulation | 21 CFR 862.1660 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-03-08 |
| Record revised | 2024-09-11 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Storage | Storage environment temperature 2 to 8 °C |
| Distribution end date | 2026-02-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NATtrol™ CT/NG/TV Positive Control | In distribution | |
| NATtrol™ HCV Virus Bundle | In distribution | |
| NATtrol™ Vaginal Bundle | In distribution | |
| NATtrol™ Methicillin-Resistant Staphylococcus aureus Positive Control | In distribution | |
| NATtrol™ SARS-Related Coronavirus 2 Positive Control | In distribution | |
| NATtrol™ SARS-Related Coronavirus 2 Positive Control | In distribution | |
| NATtrol™ Neisseria gonorrhoeae Positive Controls | In distribution | |
| NATtrol™ Chlamydia trachomatis Positive Controls | In distribution | |
| NATtrol™ Norovirus GI/GII Positive Control | In distribution | |
| NATtrol™ Vaginal Positive Control | In distribution | |
| NATtrol™ Methicillin-Resistant Staphylococcus aureus/Staphylococcus aureus | In distribution | |
| NATtrol™ Vaginal Mini Bundle | In distribution | |
| NATtrol™ Mpox Virus Negative Control | In distribution | |
| NATtrol™ Strep A Positive Control | In distribution | |
| NATtrol™ SARS-Related Coronavirus 2 Negative Control | In distribution | |
| NATtrol™ HCV Virus Negative Control | In distribution | |
| NATtrol™ Clostridium difficile Negative Control | In distribution | |
| NATtrol™ Trichomonas vaginalis Negative Control | In distribution | |
| NATtrol™ SARS-Related Coronavirus 2 Negative Control | In distribution | |
| NATtrol™ Mpox Virus Positive Control | In distribution | |
| NATtrol™ RSV Positive Control | In distribution | |
| NATtrol™ Respiratory Negative Control | In distribution | |
| NATtrol™ Respiratory Positive Control | In distribution | |
| NATtrol™ Strep A Negative Control | In distribution | |
| NATtrol™ Vaginal Negative Control | In distribution | |
| NATtrol™ HCV Virus Positive Control | In distribution | |
| NATtrol™ Respiratory/Sore Throat (R/ST) Control Kit | In distribution | |
| NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Control | In distribution | |
| NATtrol™ Meningitis/Encephalitis (ME) Controls | In distribution | |
| NATtrol™ Chlamydia trachomatis (CT) Positive Control | In distribution | |
| NATtrol™ Group B Streptococci Positive Control | In distribution | |
| NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control | In distribution | |
| NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control Swabs | In distribution | |
| NATtrol™ Norovirus GI Positive Control | In distribution | |
| NATtrol™ RP Multimarker Controls | In distribution | |
| NATtrol™ Neisseria gonorrhoeae (NG) Positive Control | In distribution | |
| NATtrol™ GI Controls | In distribution | |
| NATtrol™ Trichomonas vaginalis Positive Control | In distribution | |
| NATtrol™ Respiratory Bundle | In distribution | |
| NATtrol™ CT/NG/TV Negative Control | In distribution | |
| NATtrol™ Norovirus GII Positive Control | In distribution | |
| NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control | In distribution | |
| NATtrol™ Flu/RSV/SARS-CoV-2 Swab Control Kit | In distribution | |
| NATtrol™ Norovirus Negative Control | In distribution | |
| NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control Swabs | In distribution | |
| NATtrol™ Influenza/RSV Negative Control | In distribution | |
| NATtrol™ Clostridium difficile Positive Control | In distribution | |
| NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae Negative Controls | In distribution | |
| NATtrol™ Staphylococcus aureus Positive Control | In distribution | |
| NATtrol™ Enterovirus Positive Control | In distribution | |
| NATtrol™ Influenza A/B Positive Control | In distribution | |
| NATtrol™ Enterovirus Negative Control | In distribution | |
| NATtrol™ Group B Streptococci Negative Control | In distribution | |
| NATtrol CT/NG/TV External Run Control Kit | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Exact Diagnostics | Exact Diagnostics | 64 |
| QC Sets and Panels: Helix Elite™ | Microbiologics, Inc. | 51 |
| Helix Elite™ Molecular Standards: Inactivated Standard | Microbiologics, Inc. | 41 |
| Multichem S Plus | Techno-Path Manufacturing Ltd. | 35 |
| Virotrol | Bio-Rad Laboratories Inc. | 27 |
| Helix Elite™ Molecular Standards: Synthetic Standard | Microbiologics, Inc. | 25 |
| Multichem IA Plus | Techno-Path Manufacturing Ltd. | 17 |
| D3 | Diagnostic Hybrids, Inc. | 14 |
| Liquichek | Bio-Rad Laboratories Inc. | 10 |
| Multichem IA | Techno-Path Manufacturing Ltd. | 8 |
| QC Sets and Panels: Kwik-Stik™ 2 Pack | Microbiologics, Inc. | 8 |
| QC Sets and Panels: Kwik-Stik™ | Microbiologics, Inc. | 7 |
Showing 12 of 107. All products under Multi-Analyte Controls Unassayed
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.