FDA.reportPublic FDA data

NATtrol™

Primary DI
01220000260313
Brand
NATtrol™
Company
ZEPTOMETRIX CORPORATION
Model
NATtrol™ Vaginal Bundle
Catalog number
NATV-BU1
Device description
NATtrol™ Vaginal Bundle contains qualitative in vitro diagnostic controls, NATtrol Vaginal Positive Control (NATVPOS-6C) DI number 01220000260290, and NATtrol Vaginal Negative Control (NATVNEG-6C) DI number 01220000260306, which are intended to be used with molecular assays for the detection of Atopobium vaginae, BVAB2, Candida albicans, Candida glabrata, and Trichomonas vaginalis for the evaluation of test performance.
Published
2022-03-31
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
01220000260313PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
01220000260313012200002603131220000260313

GMDN Terms#

Term, Definition table
TermDefinition
Multiple-type vaginitis-associated organism 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 organisms associated with vaginitis in a clinical specimen. Organisms intended to be detected may include Candida or other yeast species, Gardnerella vaginalis and/or Trichomonas vaginalis.

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
1-800-274-5487zepto.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
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
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
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
01220000260498NATtrol™ZEPTOMETRIX CORPORATIONOHQ2025-07-23
00850051429578Fort Worth DiagnosticsFort Worth Diagnostics, LLCOHQ2025-06-20