NATtrol™

Primary DI
01220000260641
Brand
NATtrol™
Company
ZEPTOMETRIX CORPORATION
Model
NATtrol™ Respiratory/Sore Throat (R/ST) Control Ki
Catalog number
NATRSTK-BIO-IVD
Device description
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.
Published
2026-03-25
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OHQMulti-Analyte Controls Unassayed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OHQMulti-Analyte Controls UnassayedClinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
01220000260641PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01220000260641012200002606411220000260641

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type respiratory pathogen nucleic acid IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms (e.g., viruses and bacteria) associated with respiratory disease and/or multiple genes conferring antimicrobial resistance in microorganisms present in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-274-5487zepto.customerservice@antylia.com

Regulatory Flags#

DUNS number
081586435
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
01220000260542NATtrol™NATtrol CT/NG/TV External Run Control KitNATCTNGTV-ERCK-IVD2025-03-06
01220000260634NATtrol™ NATtrol™ Flu/RSV/SARS-CoV-2 Swab Control Kit NATFRCKL-SW-IVD 2025-12-01
01220000260450NATtrol™NATtrol™ Strep A Positive Control NATSPY-6MC-IVD2025-09-10
01220000260467NATtrol™NATtrol™ Strep A Negative Control NATSDG-6MC-IVD2025-09-10
01220000260627NATtrol™ NATtrol™ HCV Virus BundleNATHCV-BU1-IVD2025-08-06
01220000260481NATtrol™NATtrol™ GI Controls NATGIC-BIO-IVD2025-07-25
01220000260498NATtrol™NATtrol™ Meningitis/Encephalitis (ME) Controls NATMEC-BIO-IVD2025-07-23
01220000260429NATtrol™NATtrol™ Vaginal Mini BundleNATV-BU22023-12-15
01220000260238NATtrol™NATtrol™ BV Positive ControlNATBVPOS-BD2022-03-31
01220000260245NATtrol™NATtrol™ BV Negative ControlNATBVNEG-BD2022-03-31
01220000260252NATtrol™NATtrol™ Candida/TV Positive ControlNATCTVPOS-BD2022-03-31
01220000260290NATtrol™NATtrol™ Vaginal Positive ControlNATVPOS-6C2022-03-31
01220000260306NATtrol™NATtrol™ Vaginal Negative ControlNATVNEG-6C2022-03-31
01220000260313NATtrol™NATtrol™ Vaginal BundleNATV-BU12022-03-31
01220000260405NATtrol™ NATtrol™ Mpox Virus Positive ControlNATMPXPOS-6C-IVD2023-11-13
01220000260412NATtrol™NATtrol™ Mpox Virus Negative ControlNATMPXVNEG-6C-IVD2023-11-13
01220000260528NATtrol™ NATtrol™ HCV Virus Positive ControlNATHCV-6C-IVD2024-07-22
01220000260535NATtrol™ NATtrol™ HCV Virus Negative ControlNATHCVNEG-6C-IVD2024-07-22
01220000260504NATtrol™ NATtrol™ Flu/RSV/SARS-CoV-2 Positive Control SwabsNATFRC-SW-IVD2024-06-28
01220000260511NATtrol™NATtrol™ Flu/RSV/SARS-CoV-2 Negative Control SwabsNATFRCNEG-SW-IVD2024-06-28

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