FDA.reportPublic FDA data

TriVerity

Primary DI
00850028489024
Brand
TriVerity
Company
Inflammatix, Inc.
Model
TRIVERITY-2000
Catalog number
TRIVERITY-2000
Device description
The TriVerity cartridge is a single-use, disposable, multi-chambered fluidic cartridge that has been designed, manufactured, and validated for use only on the Myrna instrument. The TriVerity test is indicated for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial infections, viral infections, and noninfectious illness, as well as to determine the likelihood of 7-day need for mechanical ventilation, vasopressors, and/or renal replacement therapy in adult patients with suspected acute infection or suspected sepsis presenting to the emergency department.
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OOIReal Time Nucleic Acid Amplification System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OOIReal Time Nucleic Acid Amplification SystemClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241676000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241676000TriVerityInflammatix, Inc.2025-01-10PRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850028489031PackageGS110In Commercial Distribution
00850028489024PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850028489031008500284890318500284890310850028489031
00850028489024008500284890248500284890240850028489024

GMDN Terms#

Term, Definition table
TermDefinition
Multiple gene-mediated host immune response mRNA expression IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of the mRNA expression of multiple genes associated with a response to (suspected) infection, in a clinical specimen, using a nucleic acid technique (NAT). It is typically used for the differentiation of bacterial from viral infection, and/or sepsis from non-infectious sources of inflammation [e.g., systemic inflammatory response syndrome (SIRS)], and may also be used to predict patient outcomes by grading disease severity.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure76.142 KiloPascal101.32 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Atmospheric Pressure76.142 KiloPascal101.32 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature15 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
18666946359support@inflammatix.com

Regulatory Flags#

DUNS number
080387361
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850028489017MyrnaMYRNA-1000MYRNA-10002026-04-30
00850028489048TriVerity Level 1 Quality ControlLEVEL 1 QUALITY CONTROL2026-04-30
00850028489055TriVerity Level 2 Quality ControlLEVEL 2 QUALITY CONTROL2026-04-30
00850028489093TriVerity Verification PanelTRIVERITY-4000TRIVERITY-40002026-04-30
00850028489109TriVerity Mini Verification PanelTRIVERITY-5000TRIVERITY-50002026-04-30

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