FDA.reportPublic FDA data

NATtrol™

Primary DI
01220000260603
Brand
NATtrol™
Company
ZEPTOMETRIX CORPORATION
Model
NATtrol™ Respiratory Negative Control
Catalog number
NATRSPNEG-8C-IVD
Device description
NATtrol™ Respiratory Negative Control (NATRSPNEG-8C-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect nucleic acids from Adenovirus, Bordetella pertussis, Bordetella parapertussis, Chlamydia pneumoniae, Coronavirus, Human Metapneumovirus, Influenza A, Influenza B, Mycoplasma pneumoniae, Parainfluenza, Rhino-Enterovirus, RSV and SARS-CoV-2.
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
01220000260603PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01220000260603012200002606031220000260603

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 Temperature00

Contacts#

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

Regulatory Flags#

DUNS number
081586435
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
01220000260597NATtrol™NATtrol™ Respiratory Positive ControlNATRSPPOS-8C-IVD2026-06-04
01220000260610NATtrol™NATtrol™ Respiratory BundleNATRSP-BU1-IVD2026-06-04
01220000260641NATtrol™ NATtrol™ Respiratory/Sore Throat (R/ST) Control KiNATRSTK-BIO-IVD2026-03-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01220000260597NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
01220000260610NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
05391523442800Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
05391523442817Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
05391523442824Multichem AE TECHNO-PATH MANUFACTURING LIMITEDOHQ2026-05-11
00850051429905Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
00850051429912Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
00850051429929Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2026-04-06
05056850400052Mimix™ Geni™ OncoMix 1 DNA/RNA FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2026-03-27
05056850400069Mimix™ Geni™ Negative FFPE Reference StandardREVVITY DISCOVERY LIMITEDOHQ2026-03-27
01220000260641NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2026-03-25
70845357044432QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2026-02-10
00852720008244Birlinn™ CoV2-Flu-RSV Control Panel M509MmqciOHQ2025-12-04
01220000260634NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-12-01
01220000260450NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-09-10
01220000260467NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-09-10
70845357044340QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
70845357044395QC Sets and Panels: Helix Elite™MICROBIOLOGICS INC.OHQ2025-09-08
05056850400038Mimix™ Quantitative Multiplex FFPE reference standardREVVITY DISCOVERY LIMITEDOHQ2025-08-15
80845357044422Helix Elite Molecular StandardsMICROBIOLOGICS INC.OHQ2025-08-14
01220000260627NATtrol™ ZEPTOMETRIX CORPORATIONOHQ2025-08-06
04987270235584Lumipulse Infectious Diseases ControlsFUJIREBIO INC.OHQ2025-07-31
08718734962946CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734962953CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734962960CueSee® BGEMEurotrol B.V.OHQ2025-07-25
01220000260481NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-25
08718734962991CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963004CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963011CueSee® BGEMEurotrol B.V.OHQ2025-07-25
08718734963028CueSee® BGEMEurotrol B.V.OHQ2025-07-25