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…

Registry build 21.09.26

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.

2manufacturers in China registered for this device type
54catalogue numbers in this listing

Who Else Makes It

Concentrated in Jilin (1), Guangdong (1).

Chinese manufacturers registered for FDA product code OHQ
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

Regulatory record for NATtrol™
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

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 numbers for NATtrol™
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer