AXIOM DIAGNOSTICS, INC.

FDA Device Registration & Listing · Tampa, FL, US · Registration 3015171822

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
3015171822
FEI Number
3015171822
Entity Name
AXIOM DIAGNOSTICS, INC.
City/State/Country
Tampa, FL, US
Establishment Address
4309 W Tyson Ave, Tampa, FL 33611, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Axiom Diagnostics, Inc. (Owner Number: 10094742)
Owner / Operator Contact Address
4309 W. Tyson Avenue, Tampa, FL 33611, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

TestTrue pH 4.5 Calibrator TestTrue pH 9 Calibrator TestTrue pH 4 Calibrator TestTrue pH 11 Calibrator Test True General Purpose Reagents Test True Multi-analyte controls

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JIS Calibrator, Primary Clinical Chemistry Class 2 862.1150 2025-12-19
PPM General Purpose Reagent Pathology Class 1 864.4010 2026-02-06
JJY Multi-Analyte Controls, All Kinds (Assayed) Clinical Chemistry Class 1 862.1660 2026-02-06

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Axiom Diagnostics, Inc.
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

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-2007 Abbott Diagnostic International, Ltd. Carr 2 Km 58.0 Cruce Davila 2
Abbott AxSYM system FSH Master Calibrators (LN 7A60-30), for in vitro diagnostic use.
Z-0033-2022 Sentinel CH SpA Via Robert Koch 2
Alinity c CRP Vario Cardiac High Sensitivity Calibrator Kit (ref 07P5605) - Product Usage: use in the calibration of the Alinity c CRP Vario assay, Cardiac CRP high sensitivity method [Cardiac CRP], on the Alinity c analyzer.

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2250051 ORTHO-CLINICAL DIAGNOSTICS, INC. RARITAN, NJ, US
9612316 TOSOH AIA, INC. TOYAMA, JP
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015171822. Last updated year: 2026. Please use registration number 3015171822 when referencing this establishment in official correspondence.
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