FDA.reportPublic FDA data

NATtrol™

Primary DI
01220000260450
Brand
NATtrol™
Company
ZEPTOMETRIX CORPORATION
Model
NATtrol™ Strep A Positive Control
Catalog number
NATSPY-6MC-IVD
Device description
NATtrol™ Strep A Positive Control (NATSPY-6MC-IVD) is a qualitative in vitro diagnostic external control intended to evaluate test performance of molecular assays which detect Streptococcus pyogenes nucleic acids.
Published
2025-09-10
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
01220000260450PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01220000260450012200002604501220000260450

GMDN Terms#

Term, Definition table
TermDefinition
Beta-haemolytic Group A Streptococcus 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 Group A beta-haemolytic Streptococcus bacteria in a clinical specimen.

Storage And Handling#

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

Contacts#

Phone, Email table
PhoneEmail
1-800-274-5487diagnostic.cs@zeptometrix.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
01220000260498NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-23
00850051429578Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20
00850051429639Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20