NATtrol™ NATHCV-6C-IVD

GUDID 01220000260528

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

Hepatitis C virus nucleic acid IVD, control
Primary Device ID01220000260528
NIH Device Record Key04885669-1b53-40fe-be87-14497acb0c6d
Commercial Distribution StatusIn Commercial Distribution
Brand NameNATtrol™
Version Model NumberNATtrol™ HCV Virus Positive Control
Catalog NumberNATHCV-6C-IVD
Company DUNS081586435
Company NameZEPTOMETRIX CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com
Phone800-274-5487
Emaildiagnostic.cs@zeptometrix.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS101220000260528 [Primary]

FDA Product Code

OHQMulti-Analyte Controls Unassayed

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-30
Device Publish Date2024-07-22

On-Brand Devices [NATtrol™ ]

01220000260016NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic external run controls
01220000260078NATtrol™ Influenza/RSV Negative Control (MDZ045) is an in vitro diagnostic external run contro
01220000260061NATtrol™ Clostridium difficile Negative Control (MDZ041) is an in vitro, diagnostic external r
01220000260054NATtrol™ Clostridium difficile Positive Control (MDZ040) is an in vitro diagnostic external ru
01220000260047NATtrol™ Chlamydia trachomatis/Neisseria gonorrhoeae (CT/NG) Negative Controls (MDZ004) consis
01220000260030NATtrol™ Neisseria gonorrhoeae (NG) Positive Controls (MDZ003) consist of in vitro diagnostic
01220000260023NATtrol™ Chlamydia trachomatis (CT) Positive Controls (MDZ002) are in vitro diagnostic externa
01220000260214NATtrol™ Methicillin-Resistant Staphylococcus aureus/Staphylococcus aureus (MRSA/SA) Negative
01220000260207NATtrol™ Methicillin-Resistant Staphylococcus aureus (MRSA) Positive Control (MDZ059) is an in
01220000260177NATtrol™ Enterovirus (EV) Negative Control (MDZ056) is an in vitro diagnostic external run con
01220000260160NATtrol™ Enterovirus (EV) Positive Control (MDZ055) is an in vitro diagnostic external run con
01220000260153NATtrol™ GBS (Group B Streptococci) Negative Control (MDZ054) is an in vitro diagnostic extern
01220000260146NATtrol™ GBS (Group B Streptococci) Positive Control (MDZ053) is an in vitro diagnostic extern
01220000260139NATtrol™ Norovirus Negative Control (MDZ052) is an in vitro diagnostic external run control in
01220000260122NATtrol™ Norovirus GII Positive Control (MDZ051) is an in vitro diagnostic external run contro
01220000260115NATtrol™ Norovirus GI Positive Control (MDZ050) is an in vitro diagnostic external run control
01220000260108NATtrol™ Norovirus GI/GII Positive Control (MDZ049) is an in vitro diagnostic external run con
01220000260092NATtrol™ RSV Positive Control (MDZ047) is an in vitro diagnostic external run control, intende
01220000260085NATtrol™ Influenza A/B Positive Control (MDZ046) is an in vitro diagnostic external run contro
01220000260283NATCTNGNEG-6MC is a qualitative in vitro diagnostic external run control intended to be used wit
01220000260276NATNG-6MC is a qualitative in vitro diagnostic external run control intended to be used with mol
01220000260269NATCT(434)-6MC is a qualitative in vitro diagnostic external run control intended to be used wit
01220000260313NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtrol Vaginal Pos
01220000260306NATtrol™ Vaginal Negative Control (NATVNEG-6C) is a qualitative in vitro diagnostic control in
01220000260290NATtrol™ Vaginal Positive Control (NATVPOS-6C) is a qualitative in vitro diagnostic control in
01220000260252NATtrol™ Candida/TV Positive Control (NATCTVPOS-BD) is intended for use as an assayed quality
01220000260245NATtrol™ BV Negative Control (NATBVNEG-BD) is intended for use as an assayed quality control m
01220000260238NATtrol™ BV Positive Control (NATBVPOS-BD) is intended for use as an assayed quality control m
01220000260221The NATtrol™ Staphylococcus aureus (SA) Positive Control is an unassayed in vitro diagnostic e
12200002600184The NATtrol™ Trichomonas vaginalis (T. vaginalis) Positive Control is an unassayed in vitro di
01220000260191The NATtrol™ Trichomonas vaginalis (T. vaginalis) Negative Control is an unassayed in vitro di
01220000260184The NATtrol™ Trichomonas vaginalis (T. vaginalis) Positive Control is an unassayed in vitro di
01220000260375The NATtrol™ SARS-Related Coronavirus 2 Negative Control is an unassayed in vitro diagnostic e
01220000260368The NATtrol™ SARS-Related Coronavirus 2 Positive Control is an unassayed in vitro diagnostic e
01220000260351The NATtrol™ SARS-Related Coronavirus 2 Negative Control is an unassayed in vitro diagnostic e
01220000260344The NATtrol™ SARS-Related Coronavirus 2 Positive Control is an unassayed in vitro diagnostic e
01220000260337The NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control is an unassayed in vitro diagnostic external
01220000260320The NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control is an unassayed in vitro diagnostic external
01220000260399NATtrol™ CT/NG/TV Negative Control is a qualitative external run control intended to be used
01220000260382NATtrol™ CT/NG/TV Positive Control is a qualitative external run control intended to be used
01220000260412NATtrol™ Mpox Virus Negative Control (NATMPXVNEG-6C-IVD) is a qualitative in vitro diagnostic
01220000260405NATtrol™ Mpox Virus Positive Control (NATMPXVPOS-6C-IVD) is a qualitative in vitro diagnostic
01220000260429NATtrol™ Vaginal Mini Bundle is a packaging configuration that contains qualitative in vitro d
01220000260511NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control Swabs (NATFRCNEG-SW-IVD) is a qualitative in vit
01220000260504NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control Swab (NATFRC-SW-IVD) is a qualitative in vitro di
01220000260535NATtrol™ HCV Virus Negative Control (NATHCVNEG-6C-IVD) is a qualitative in vitro diagnostic ex
01220000260528NATtrol™ HCV Virus Positive Control (NATHCV-6C-IVD) is a qualitative in vitro diagnostic exter
01220000260542NATtrol™ CT/NG/TV External Run Control Kit are qualitative positive and negative external run
01220000260498NATtrol™ Meningitis/Encephalitis (ME) Controls (NATMEC-BIO-IVD) are qualitative in vitro diagn
01220000260481NATtrol™ GI Controls (NATGIC-BIO-IVD) are qualitative in vitro diagnostic external controls in

Trademark Results [NATtrol]

Mark Image

Registration | Serial
Company
Trademark
Application Date
NATTROL
NATTROL
86345880 4695686 Live/Registered
ZeptoMetrix Corporation
2014-07-23
NATTROL
NATTROL
78680526 not registered Dead/Abandoned
ZeptoMetrix Corp.
2005-07-28
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