FDA.reportPublic FDA data

TriVerity Level 2 Quality Control

Primary DI
00850028489055
Brand
TriVerity Level 2 Quality Control
Company
Inflammatix, Inc.
Model
LEVEL 2 QUALITY CONTROL
Device 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.
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JJYMulti-Analyte Controls, All Kinds (Assayed)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJYMulti-Analyte Controls, All Kinds (Assayed)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850028489042PackageGS110In Commercial Distribution
00850028489055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085002848904220850028489042
00850028489055008500284890558500284890550850028489055

GMDN Terms#

Term, Definition table
TermDefinition
Multiple bacterial/viral infection-associated mRNA expression 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 mRNA expression of specific genes associated with response to acute infection with multiple bacterial and viral pathogens in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Atmospheric Pressure84.556 KiloPascal101.32 KiloPascal
Handling Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius30 Degrees Celsius
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
18666946359support@inflammatix.com

Regulatory Flags#

DUNS number
080387361
Device count
1
Premarket exempt
true
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
00850028489024TriVerityTRIVERITY-2000TRIVERITY-20002026-04-30
00850028489048TriVerity Level 1 Quality ControlLEVEL 1 QUALITY CONTROL2026-04-30
00850028489093TriVerity Verification PanelTRIVERITY-4000TRIVERITY-40002026-04-30
00850028489109TriVerity Mini Verification PanelTRIVERITY-5000TRIVERITY-50002026-04-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850028489048TriVerity Level 1 Quality ControlInflammatix, Inc.JJY2026-04-30
00850028489093TriVerity Verification PanelInflammatix, Inc.JJY2026-04-30
00850028489109TriVerity Mini Verification PanelInflammatix, Inc.JJY2026-04-30
00850011135747VALIDATELgc Clinical Diagnostics, Inc.JJY2026-04-24
00850075957330KOVA-Trol II Low AbnormalLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957378KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957385KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957392KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957408KOVA-Trol I High Abnormal With Urobilinogen Lgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957415KOVA-Trol III Normal with hCGLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850075957439KOVA-Trol I High Abnormal with Urobilinogen Value AssignmentLgc Clinical Diagnostics, Inc.JJY2026-04-17
00850011135822VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135839VALIDATELgc Clinical Diagnostics, Inc.JJY2025-10-08
00850011135716ValidateLgc Clinical Diagnostics, Inc.JJY2024-09-05
00852676007087Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
00852676007094Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
00852676007100Phoenix DiagnosticsPHOENIX DIAGNOSTICS, INC.JJY2023-08-09
03610522248377LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248384LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248391LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248407LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248667LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248674LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248681LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248698LiquichekBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248872InteliQBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248889InteliQBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248896InteliQBIO-RAD LABORATORIES, INC.JJY2023-01-31
03610522248902InteliQBIO-RAD LABORATORIES, INC.JJY2023-01-31
03607360047668HYPERGAMMA CONTROL (20)SEBIAJJY2022-12-12