Device
The TriVerity Quality Controls are intended for use as optional quality control materials to assess the performance of the TriVerity Test System. TriVerity Quality Controls are des...
Manufacturer
Inflammatix, Inc.
Inflammatix, Inc.
Model: LEVEL 2 QUALITY CONTROL
DI: 00850028489055
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 Quality Controls are intended for use as optional quality control materials to assess the performance of the TriVerity Test System. TriVerity Quality Controls are designed to be used by laboratory personnel and healthcare professionals, according to individual organizational policies for quality control use when verifying or monitoring system performance. TriVerity Quality Controls are compatible for use with TriVerity cartridges used with the Myrna instrument.
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
33b86ca5-b419-4865-bb16-122e8729b5d5
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
Item #1 - Pkg Type:
Box
Item #1 - Device ID:
20850028489042
Item #1 - Pkg Status:
In Commercial Distribution
Item #1 - Pkg Quantity:
10
Item #1 - Device ID Type:
Package
Item #1 - Contains DINumber:
00850028489055
Item #1 - Device ID Issuing Agency:
GS1
Item #2 - Device ID:
00850028489055
Item #2 - Device ID Type:
Primary
Item #2 - Device ID 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:
2
Item #1 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #1 - Storage Handling High - @attributes - Value:
8
Item #1 - Storage Handling Type:
Storage Environment Temperature
Item #2 - Storage Handling Low - @attributes - Unit:
KiloPascal
Item #2 - Storage Handling Low - @attributes - Value:
84.556
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:
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:
Degrees Celsius
Item #4 - Storage Handling Low - @attributes - Value:
15
Item #4 - Storage Handling High - @attributes - Unit:
Degrees Celsius
Item #4 - Storage Handling High - @attributes - Value:
30
Item #4 - Storage Handling Type:
Handling Environment Temperature