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Genbio

US

Last updated September 17, 2026

Information

Country
US
Address
15222 AVE. OF SCIENCE, San Diego, CA, 92128
Website
genbio.com
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
858-592-9300
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
2027113
DUNS Number
940425333

Catalogue (50)

DeviceModel / ReferenceRegistriesClassStatus
IMMUNOWELL JCV IgG Test 804-3810
FDA UDI
Class IIActive
ImmunoDOT Salmonella typhi 800-4040
FDA UDI
Class IIActive
ImmunoWELL TPO IgG Quantitative Test 800-3020
FDA UDI
Class IIUnknown
ImmunoDOT Leptospira IgM 800-4032
FDA UDI
Class IIActive
ImmunoFA Toxoplasma IgG Conjugate 800-1202
FDA UDI
Class IIUnknown
ImmunoFA Toxoplasma IgG 800-1200
FDA UDI
Class IIUnknown
ImmunoWELL Borrelia (Lyme) 800-3110
FDA UDI
Class IIUnknown
ImmunoDOT Thyroid Positive Control 800-3912
FDA UDI
Class IIUnknown
Immunodot™ Rickettsia Conorii 800-4010
FDA UDI
Class IActive
ImmunoFA Toxoplasma IgM Conjugate 800-1309
FDA UDI
Class IIUnknown
ImmunoDOT Leptospira IgM 800-4034
FDA UDI
Class IIActive
ImmunoDOT Autoimmunity Panel 1 800-5189
FDA UDI
Class IIActive
ImmunoDOT Autoimmunity Panel 4 800-5425
FDA UDI
Class IIUnknown
ImmunoDOT Thyroid Autoimmunity Panel 800-5889
FDA UDI
Class IIUnknown
ImmunoWELL Cardiolipin (IgG) Test 800-3090
FDA UDI
Class IIUnknown
ImmunoDOT Negative Control 800-3920
FDA UDI
Class IIActive
ImmunoWELL Thyroglobulin IgG Quantitative Test 800-3030
FDA UDI
Class IIUnknown
ImmunoDOT Serum Control D 800-3918
FDA UDI
Class IIActive
ImmunoFA Toxoplasma IgG High Control 800-1205
FDA UDI
Class IIUnknown
ImmunoFA Toxoplasma IgM 800-1300
FDA UDI
Class IIUnknown
ImmunoWELL Cardiolipin (IgM) Test 800-3100
FDA UDI
Class IIUnknown
IMMUNODOT™ Rickettsia Typhi 800-4020
FDA UDI
Class IActive
ImmunoFA 10x PBS 800-1006
FDA UDI
Class IIUnknown
ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgG) TEST 800-3120
FDA UDI
Class IActive
ImmunoFA Toxoplasma Slides 800-1201
FDA UDI
Class IIUnknown
ImmunoFA Toxoplasma IgM Positive Control 800-1341
FDA UDI
Class IIUnknown
ImmunoDOT Borrelia Positive Control 800-3905
FDA UDI
Class IIUnknown
ImmunoFA Toxoplasma IgG Low Control 800-1204
FDA UDI
Class IIUnknown
ImmunoWELL™ MYCOPLASMA PNEUMONIAE ANTIBODY (IgM) TEST 800-3130
FDA UDI
Class IActive
ImmunoDOT Thyroid Autoimmunity Panel 800-5825
FDA UDI
Class IIUnknown
Immunodot™ Coxiella Burnetii (q Fever) 800-4050
FDA UDI
Class IActive
ImmunoFA Toxoplasma IgG Negative Control 800-1203
FDA UDI
Class IIUnknown
IMMUNOFLOW™ Mycoplasma pneumoniae IgM Test 800-7005
FDA UDI
Class IActive
ImmunoDOT Borrelia Test 800-5025
FDA UDI
Class IIUnknown
ImmunoDOT Autoimmunity Panel 4 800-5489
FDA UDI
Class IIUnknown
ImmunoFA Mounting Fluid 800-1025
FDA UDI
N/AUnknown
ImmunoFA 10x PBS 800-1005
FDA UDI
Class IIUnknown
ImmunoFA Toxoplasma Slides 800-1207
FDA UDI
Class IIUnknown
ImmunoDOT Leptospira IgM 800-4030
FDA UDI
Class IIActive
ImmunoDOT Autoimmunity Panel 1 800-5125
FDA UDI
Class IIActive
Immunowell Vca Igm Test K973939
FDA 510(k)
Class IActive
Mmuno Dot Borrelia Dot Blot M Test K953683
FDA 510(k)
Class IIActive
Immuno Dot Borrelia Dot Blot G Test K953682
FDA 510(k)
Class IIActive
Immunowell Mycoplasma Pneumonia Antibody (igm) Test (3130) K963054
FDA 510(k)
Class IActive
Immunowell Mycoplasma Pneumonia Antibody (igg) Test 3120 K963055
FDA 510(k)
Class IActive
Immunodot Mono-M Test K974244
FDA 510(k)
Class IActive
Immunowell Ebv Vca Igg Test K973940
FDA 510(k)
Class IActive
Immunowell Ebna Igg Test K973941
FDA 510(k)
Class IActive
Immunodot Mono-G Test K974226
FDA 510(k)
Class IActive
Immunowell Ea (d) Igg Test K010301
FDA 510(k)
Class IActive

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