NATtrol™

Primary DI
01220000260016
Brand
NATtrol™
Company
ZEPTOMETRIX CORPORATION
Model
NATtrol™ RP Multimarker Controls
Catalog number
MDZ001
Device description
NATtrol™ RP Multimarker Controls (MDZ001) consist of in vitro diagnostic external run controls intended for use with qualitative molecular assays. 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 error. NATtrol™ RP Multimarker Controls contain intact organisms and should be run in a manner identical to that used for clinical specimens.NATtrol™ RP Multimarker Controls are formulated with purified, intact organisms that have been chemically modified to render them non-infectious and refrigerator stable. Each control pack contains 3 x 0.75 mL vials of RP Multimarker 1 and 3 x 0.75 mL vials of RP Multimarker 2. NATtrol™ RP Multimarker Controls are formulated in a Purified Protein Matrix that is fully commutable with true clinical specimens.
Published
2020-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
01220000260016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01220000260016012200002600161220000260016

GMDN Terms#

Term, Definition table
TermDefinition
Multiple 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 different microorganisms typically associated with respiratory disease and/or one 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

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
184020902
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
01220000260597NATtrol™NATtrol™ Respiratory Positive ControlNATRSPPOS-8C-IVD2026-06-04
01220000260603NATtrol™NATtrol™ Respiratory Negative ControlNATRSPNEG-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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01220000260597NATtrol™ZEPTOMETRIX CORPORATIONOHQ2026-06-04
01220000260603NATtrol™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
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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
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