SPEEDX PTY LTD

FDA Device Registration & Listing · Eveleigh New South Wales, AU · Registration 3012113276

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
3012113276
FEI Number
3012113276
Entity Name
SPEEDX PTY LTD
City/State/Country
Eveleigh New South Wales, AU
Establishment Address
Suite 102, National Innovation Centre, 4 Cornwallis Street, Eveleigh New South Wales 2015, AU
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device
Owner / Operator
SpeeDx Pty Ltd (Owner Number: 10057454)
Owner / Operator Contact Address
Suite 102, National Innovation Centre, 4 Cornwallis Street, Eveleigh, AU-NSW 2015, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Positive Control HSV/VZV/TP ResistancePlus MG Positive Control Positive Control Flu/RSV/SARS ResistancePlus GC Control

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2018-04-06

Official Correspondent

No official correspondent registered.

US Agent Details

Jeremy Stackawitz Business: SpeeDx Inc. Email: jeremys@speedx.com.au Phone: (215) 4329629

Related Public Records

Same Entity

SpeeDx Pty Ltd
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
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23
K143687 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material 2015-07-17
K143376 Siemens Healthcare Diagnostics, Inc. ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material 2014-12-23

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012113276. Last updated year: 2026. Please use registration number 3012113276 when referencing this establishment in official correspondence.
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