Device
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...
Manufacturer
Inflammatix, Inc.
Inflammatix, Inc.
Model: TRIVERITY-2000
Catalog: TRIVERITY-2000
DI: 00850028489024
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: Yes
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
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.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
684c3982-7b53-4615-b515-83dcb10f823c
Distribution Status:
In Commercial Distribution
DUNS Number:
080387361
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
Yes
Serial Number Tracked:
No
Manufacturing Date Tracked:
No
Expiration Date Tracked:
Yes
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
00850028489031
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00850028489024
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00850028489024
Item #2 - Device ID Type:
Primary
Item #2 - Device ID Issuing Agency:
GS1
GMDN
Code: 66291
Name: Multiple gene-mediated host immune response mRNA expression IVD, kit, nucleic acid technique (NAT)
Definition:
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.
FDA Product Codes
OOI
Real Time Nucleic Acid Amplification System
Premarket Submissions
Submission Number:
K241676
Supplement Number:
000
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
15
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
30
Item #1 - Storage Handling Type:
Handling Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling Low - @attributes - Value:
15
Item #2 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #2 - Storage Handling High - @attributes - Value:
30
Item #2 - Storage Handling Type:
Storage Environment Temperature
Item #3 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling Low - @attributes - Value:
20
Item #3 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #3 - Storage Handling High - @attributes - Value:
80
Item #3 - Storage Handling Type:
Handling Environment Humidity
Item #4 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #4 - Storage Handling Low - @attributes - Value:
76.142
Item #4 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #4 - Storage Handling High - @attributes - Value:
101.32
Item #4 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #5 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling Low - @attributes - Value:
20
Item #5 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #5 - Storage Handling High - @attributes - Value:
80
Item #5 - Storage Handling Type:
Storage Environment Humidity
Item #6 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #6 - Storage Handling Low - @attributes - Value:
76.142
Item #6 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #6 - Storage Handling High - @attributes - Value:
101.32
Item #6 - Storage Handling Type:
Storage Environment Atmospheric Pressure