GENBIO

FDA Device Registration & Listing · San Diego, CA, US · Registration 2027113

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
2027113
FEI Number
2027113
Entity Name
GENBIO
City/State/Country
San Diego, CA, US
Establishment Address
15222 AVE. OF SCIENCE, Suite A, San Diego, CA 92128, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GenDx LLC (Owner Number: 2027113)
Owner / Operator Contact Address
15222 AVE OF SCIENCE, SUITE A, --, San Diego, CA 92128, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

ImmunoWELL Borrelia (Lyme) ImmunoDOT Rickettsia typhi ImmunoDOT Salmonella typhi ImmunoWELL Mycoplasma Pneumoniae (IgG Antibody) ImmunoDOT Rickettsia Conorii ImmunoWELL anti-JCV IgG Test ImmunoDOT Leptospira IgM ImmunoFLOW Mycoplasma IgM Test ImmunoDOT Autoimmunity Panel 1 ImmunoDOT Coxiella burnetii (Q Fever)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LSR Reagent, Borrelia Serological Reagent Microbiology Class 2 866.3830 2008-08-24
LSQ Reagent, Rickettsia Serological Microbiology Class 1 866.3500 2008-08-24
GRM Antisera, All Groups, Salmonella Spp. Microbiology Class 2 866.3550 2008-08-25
LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. Microbiology Class 1 866.3375 2008-11-07
LSQ Reagent, Rickettsia Serological Microbiology Class 1 866.3500 2008-08-24
OYP Anti-Jcv Antibody Detection Assay Microbiology Class 2 866.3336 2024-01-02
GRY Antigens, All, Leptospira Spp. Microbiology Class 2 866.3350 2008-08-24
GSA Antisera, All Mycoplasma Spp. Microbiology Class 1 866.3375 2023-05-12
LJM Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls Immunology Class 2 866.5100 2008-07-10
GPJ Antiserum, Fluorescent, Q Fever Microbiology Class 1 866.3500 2012-06-14

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

GenDx LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027113. Last updated year: 2026. Please use registration number 2027113 when referencing this establishment in official correspondence.
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