Device
The TriVerity Verification Panel is intended solely for use with the TriVerity Test System for verification and training purposes. The TriVerity Verification Panel contains synthet...
Manufacturer
Inflammatix, Inc.
Inflammatix, Inc.
Model: TRIVERITY-4000
Catalog: TRIVERITY-4000
DI: 00850028489093
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: Yes
Rx: No
OTC: No
First Published: 2026-04-30
Current Version: 2026-05-08
Description
The TriVerity Verification Panel is intended solely for use with the TriVerity Test System for verification and training purposes. The TriVerity Verification Panel contains synthetic RNA transcripts in an RNA free blood matrix. It is not intended to diagnose, treat, cure, or prevent any disease. Results generated with the kit must not be used for patient diagnosis.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
b1fc0f36-fac0-49c5-a004-b33fed3092db
Distribution Status:
In Commercial Distribution
DUNS Number:
080387361
Device Count:
1
DM Exempt:
No
Premarket Exempt:
Yes
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
Device ID:
00850028489093
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 66290
Name: Multiple bacterial/viral infection-associated mRNA expression IVD, control
Definition:
A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of mRNA expression of specific genes associated with response to acute infection with multiple bacterial and viral pathogens in a clinical specimen.
FDA Product Codes
JJY
Multi-Analyte Controls, All Kinds (Assayed)
Environmental Conditions
Item #1 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling Low - @attributes - Value:
-80
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
-80
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling Low - @attributes - Value:
76.142
Item #2 - Storage Handling High - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling High - @attributes - Value:
101.32
Item #2 - Storage Handling Type:
Handling Environment Atmospheric Pressure
Item #3 - Storage Handling Low - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling Low - @attributes - Value:
15
Item #3 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #3 - Storage Handling High - @attributes - Value:
30
Item #3 - Storage Handling Type:
Handling Environment Temperature
Item #4 - Storage Handling Low - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling Low - @attributes - Value:
20
Item #4 - Storage Handling High - @attributes - Unit:
Percent (%) Relative Humidity
Item #4 - Storage Handling High - @attributes - Value:
80
Item #4 - Storage Handling Type:
Handling Environment Humidity