IVD RESEARCH, LLC.

FDA Device Registration & Listing · Carlsbad, CA, US · Registration 2031468

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
2031468
FEI Number
3002023342
Entity Name
IVD RESEARCH, LLC.
City/State/Country
Carlsbad, CA, US
Establishment Address
5909 SEA LION PLACE, SUITE D, Carlsbad, CA 92010, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
IVD RESEARCH, LLC. (Owner Number: 9034173)
Owner / Operator Contact Address
5909 SEA LION PLACE, SUITE D, --, Carlsbad, CA 92010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

INDIRECT FLUORESCENT ANTIBODY TEST , ENTAMOEBA HISTOLYTICA REL SP Giardia/Cryptosporidium Combo Stool Antigen Detection ELISA GIARDIA STOOL ANTIGEN ELISA IVD Research Schistosoma ELISA Test Kit Cryptosporidium Antigen Detection ELISA Giardia/Cryptosporidium Combo Stool Antigen Detection ELISA

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
GWD Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp Microbiology Class 2 866.3220 1998-06-16
MHI Giardia Spp. Microbiology Class 2 866.3220 2001-06-13
GNH Antigen, Fluorescent Antibody Test, Schistosoma Mansoni Microbiology Class 1 866.3600 2003-09-17
NGA Test, Follicle Stimulating Hormone (Fsh), Over The Counter Clinical Chemistry Class 1 862.1300 2021-07-07
MHJ Cryptosporidium Spp. Microbiology Class 2 866.3220 2001-06-13

Official Correspondent

Chris Lambillotte

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

IVD RESEARCH, LLC.
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
K930451 Alexon, Inc. PROSPEC T GIARDIA MICROTITER ASSAY 1993-04-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031468. Last updated year: 2026. Please use registration number 2031468 when referencing this establishment in official correspondence.
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