Data / Medical devices / United States / Genbio
Genbio: FDA-registered device maker in San Diego, CA, United States, 7 510(k) clearances
Genbio is registered with the FDA (registration 2027113) in San Diego, CA, United States. It lists 9 device types. The FDA files 7 510(k) clearances under its listings, the newest dated November 22, 2000. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2027113
- Address
- 15222 AVE. OF SCIENCE Suite A, San Diego, CA, United States, 92128
- Owner or operator
- GenDx LLC (2027113)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- December 16, 1998
- Registered through
- 2026
- Brand names listed
- ImmunoDOT Autoimmunity Panel 1, ImmunoDOT Coxiella burnetii (Q Fever), ImmunoDOT Leptospira IgM, ImmunoDOT Rickettsia Conorii, ImmunoDOT Rickettsia typhi, ImmunoDOT Salmonella typhi, ImmunoFLOW Mycoplasma IgM Test, ImmunoWELL Borrelia (Lyme) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Anti-Jcv Antibody Detection Assay | OYP | 2 | Manufacturer for export | accessdata.fda.gov |
| Antigens, All, Leptospira Spp. | GRY | 2 | Manufacturer | accessdata.fda.gov |
| Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | LJM | 2 | Manufacturer | accessdata.fda.gov |
| Antisera, All Groups, Salmonella Spp. | GRM | 2 | Manufacturer | accessdata.fda.gov |
| Antisera, All Mycoplasma Spp. | GSA | 1 | Manufacturer | accessdata.fda.gov |
| Antiserum, Fluorescent, Q Fever | GPJ | 1 | Manufacturer | accessdata.fda.gov |
| Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. | LJZ | 1 | Manufacturer | accessdata.fda.gov |
| Reagent, Borrelia Serological Reagent | LSR | 2 | Manufacturer | accessdata.fda.gov |
| Reagent, Rickettsia Serological | LSQ | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 22, 2000 | K002024 | PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA | GRY | Substantially Equivalent | Panbio, Inc. | accessdata.fda.gov |
| March 13, 1998 | K971591 | INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) | LSQ | Substantially Equivalent | David C. Bishop, Ph.D. | accessdata.fda.gov |
| May 5, 1997 | K963054 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) | LJZ | Substantially Equivalent | Genbio | accessdata.fda.gov |
| May 2, 1997 | K963055 | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 | LJZ | Substantially Equivalent | Genbio | accessdata.fda.gov |
| February 9, 1993 | K920569 | INDXTM DIP-S-TICKSTM | LSQ | Substantially Equivalent | Intercare Diagnostics, Inc. | accessdata.fda.gov |
| December 20, 1991 | K911590 | IMMUNOWELL BORRELIA (LYME)TEST | LSR | Substantially Equivalent | General Biometrics, Inc. | accessdata.fda.gov |
| December 5, 1989 | K896347 | IMMUNODOT AUTOIMMUNE SCREENING PANEL 1 | LJM | Substantially Equivalent | General Biometrics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 11, 2013 | 64348 | Class II | Terminated | ANTI-BORRELIA (LYME) MICROPLATE EIA Kit, Catalog # 32507 Kit Lot Number 120960. Package Insert Supplement: Calibrator-1206 U/mL, Positive Control-228 - 532 U/mL, and Negative Control-<120 U/mL; Manufactured by Innominata | Multiple incidents of low-reacting assay plates. | accessdata.fda.gov |
Compare with other makers
- All makers of Reagent, Borrelia Serological Reagent
- All makers of Antigens, All, Leptospira Spp.
- All makers of Reagent, Rickettsia Serological
- All makers of Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
- All makers of Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls
- All makers of Antisera, All Mycoplasma Spp.
Updated March 8, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.