inflammatix.comTriVerity
Inflammatix, Inc.
INFLAMMATIX
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3022977716 | 3022977716 | INFLAMMATIX | 1 | N | 2026-01-01 | 540 Oakmead Pkwy Sunnyvale CA US 94085 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850028489017 | Myrna - The Myrna instrument is an automated in vitro diagnostic (IVD) device intended for use with FDA cleared or approved Inflammatix cartridges only. The Myrna instrument is intended to be used by healthcare professionals, and exclusively with Inflammatix test cartridges.The Myrna instrument is a platform instrument that provides pneumatic, thermal, motor, and optical control to complete the steps in an assay and runs a classifier to process the data acquired and produce the test results. An included touch screen display provides the primary method of input and, in concert with a graphical user interface, guides the user through the steps necessary to initiate a run. An outward facing barcode scanner acts as the primary method for entering information into the instrument software during a normal test workflow. | 18666946359 | support@inflammatix.com |
| 00850028489024 | TriVerity - 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. | 18666946359 | support@inflammatix.com |
| 00850028489048 | TriVerity Level 1 Quality Control - 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. | 18666946359 | support@inflammatix.com |
| 00850028489055 | TriVerity Level 2 Quality Control - 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. | 18666946359 | support@inflammatix.com |
| 00850028489093 | TriVerity Verification Panel - 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. | 18666946359 | support@inflammatix.com |
| 00850028489109 | TriVerity Mini Verification Panel - The TriVerity Mini Verification panel is intended solely for use with the TriVerity Test System for verification and training purposes. The TriVerity Mini-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 this kit must not be used for patient diagnosis.The TriVerity Mini-Verification Panel is a version of the full TriVerity Verification Panel offered in a reduced format, consisting of a subset of representative tubes from the full 22-tube panel. This abbreviated version is intended for use in partial system verifications or periodic performance checks. | 18666946359 | support@inflammatix.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 337545 | 1555581898 | K241676 | TriVerity | PRE | 2025-01-10 |
| 337545 | 1213949847 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| PRE | 1 | 2025-01-10 |
PMN#
GUDID#
Myrna - The Myrna instrument is an automated in vitro diagnostic (IVD) device intended for use with FDA cleared or approved Inflammatix cartridges only. The Myrna instrument is intended to be used by healthcare professionals, and exclusively with Inflammatix test cartridges.The Myrna instrument is a platform instrument that provides pneumatic, thermal, motor, and optical control to complete the steps in an assay and runs a classifier to process the data acquired and produce the test results. An included touch screen display provides the primary method of input and, in concert with a graphical user interface, guides the user through the steps necessary to initiate a run. An outward facing barcode scanner acts as the primary method for entering information into the instrument software during a normal test workflow.
2026-04-30
TriVerity - 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.
2026-04-30
TriVerity Level 1 Quality Control - 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.
2026-04-30
TriVerity Level 2 Quality Control - 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.
2026-04-30
TriVerity Verification Panel - 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.
2026-04-30
TriVerity Mini Verification Panel - The TriVerity Mini Verification panel is intended solely for use with the TriVerity Test System for verification and training purposes. The TriVerity Mini-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 this kit must not be used for patient diagnosis.The TriVerity Mini-Verification Panel is a version of the full TriVerity Verification Panel offered in a reduced format, consisting of a subset of representative tubes from the full 22-tube panel. This abbreviated version is intended for use in partial system verifications or periodic performance checks.
2026-04-30