INFLAMMATIX

FDA Device Registration & Listing · Sunnyvale, CA, US · Registration 3022977716

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3022977716
FEI Number
3022977716
Entity Name
INFLAMMATIX
City/State/Country
Sunnyvale, CA, US
Establishment Address
540 Oakmead Pkwy, Sunnyvale, CA 94085, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Inflammatix (1 650-443-3030) (Owner Number: 10092481)
Owner / Operator Contact Address
540 Oakmead Pkwy, Sunnyvale, CA 94085, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TriVerity Myrna TriVerity Quality Control Level 1 TriVerity Quality Control Level 2 TriVerity Mini Verification Panel TriVerity Verification Panel

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OOI Real Time Nucleic Acid Amplification System Clinical Chemistry Class 2 862.2570 2025-02-25
PRE Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers Microbiology Class 2 866.3215 2025-02-25
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2025-03-13

Official Correspondent

Diana Lane

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Inflammatix (1 650-443-3030)
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K990531 Ortho-Clinical Diagnostics, Inc. VITROS IMMUNODIAGNOSTIC PRODUCTS ONCOLOGY CONTROLS 1999-03-12
K982637 Diagnostic Products Corp. IMMULITE PSA CONTROL MODULE, MODEL LPSCM 1998-08-12
K012468 Dade Behring, Inc. MODIFICATION TO N/T PROTEIN CONTROL SL 2001-09-04

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1524213 MERIDIAN BIOSCIENCE, INC. Cincinnati, OH, US
3004530258 CEPHEID Sunnyvale, CA, US
3003795116 ROCHE DIAGNOSTICS INTERNATIONAL LTD. ROTKREUZ Zug, CH
3003366417 LRE MEDICAL GMBH NOERDLINGEN Bavaria, DE
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3022977716. Last updated year: 2026. Please use registration number 3022977716 when referencing this establishment in official correspondence.
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