This page includes the latest FDA filings for Genbio. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 2027113 |
| FEI Number | 2027113 |
| Name | GENBIO |
| Owner & Operator | Innominata dba GenBio |
| Contact Address | 15222 AVE. OF SCIENCE, SUITE A -- San Diego CA 92128 US |
| Official Correspondent |
|
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 15222 AVE. OF SCIENCE Suite A Rancho Bernardo, CA 92128 US |
| Establishment Type |
|
Device Company | Device | Date |
|---|---|---|
GENBIO [Innominata dba GenBio] | CorneaCold | 2019-08-14 |
| Genbio | ImmunoDOT Thyroid Autoimmunity Panel 5889 | 2018-07-06 |
| Genbio | ImmunoDOT Thyroid Autoimmunity Panel 5825 | 2018-07-06 |
| Genbio | ImmunoDOT Autoimmunity Panel 4 5489 | 2018-07-06 |
| Genbio | ImmunoDOT Autoimmunity Panel 4 5425 | 2018-07-06 |
| Genbio | ImmunoDOT Autoimmunity Panel 1 5189 | 2018-07-06 |
| Genbio | ImmunoDOT Autoimmunity Panel 1 5125 | 2018-07-06 |
| Genbio | ImmunoDOT Borrelia Test 5025 | 2018-07-06 |
| Genbio | ImmunoDOT Negative Control 3920 | 2018-07-06 |
| Genbio | ImmunoDOT Serum Control D 3918 | 2018-07-06 |
| Genbio | ImmunoDOT Thyroid Positive Control 3912 | 2018-07-06 |
| Genbio | ImmunoDOT Borrelia Positive Control 3905 | 2018-07-06 |
| Genbio | ImmunoWELL Borrelia (Lyme) 3110 | 2018-07-06 |
| Genbio | ImmunoWELL Cardiolipin (IgM) Test 3100 | 2018-07-06 |
| Genbio | ImmunoWELL Cardiolipin (IgG) Test 3090 | 2018-07-06 |
| Genbio | ImmunoWELL Thyroglobulin IgG Quantitative Test 3030 | 2018-07-06 |
| Genbio | ImmunoWELL TPO IgG Quantitative Test 3020 | 2018-07-06 |
| Genbio | ImmunoFA Toxoplasma IgM Positive Control 1341 | 2018-07-06 |
| Genbio | ImmunoFA Toxoplasma IgM Conjugate 1309 | 2018-07-06 |
| Genbio | ImmunoFA Toxoplasma IgM 1300 | 2018-07-06 |
| Genbio | ImmunoFA Toxoplasma Slides 1207 | 2018-07-06 |
| Genbio | ImmunoFA Toxoplasma IgG High Control 1205 | 2018-07-06 |
| Genbio | ImmunoFA Toxoplasma IgG Low Control 1204 | 2018-07-06 |
| Genbio | ImmunoFA Toxoplasma IgG Negative Control 1203 | 2018-07-06 |
| Genbio | ImmunoFA Toxoplasma IgG Conjugate 1202 | 2018-07-06 |
| Genbio | ImmunoFA Toxoplasma Slides 1201 | 2018-07-06 |
| Genbio | ImmunoFA Toxoplasma IgG 1200 | 2018-07-06 |
| Genbio | ImmunoFA Mounting Fluid 1025 | 2018-07-06 |
| Genbio | ImmunoFA 10x PBS 1006 | 2018-07-06 |
| Genbio | ImmunoFA 10x PBS 1005 | 2018-07-06 |
| Genbio | ImmunoDOT Leptospira IgM 4032 | 2018-07-06 |
| Genbio | ImmunoDOT Leptospira IgM 4034 | 2018-07-06 |
| Genbio | ImmunoDOT Leptospira IgM 4030 | 2018-07-06 |
| Genbio | ImmunoDOT Salmonella typhi 4040 | 2018-03-29 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Coxiella burnetii (Q Fever) | 2012-06-14 |
GENBIO [Innominata dba GenBio] | ImmunoFLOW Mycoplasma Pneumoniae IgM | 2010-12-10 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Mycoplasma Pneumoniae (IgG Antibody) | 2008-11-07 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Mycoplasma Pneumoniae (IgM Antibody) | 2008-11-07 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Herpes Simplex Virus (HSV) Type 2 (recombinant pr | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Herpes Simplex Virus IgM Typing Test | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Herpes Simplex Virus (HSV) Type 1 (recombinant pr | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoDOT HSV Typing | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Autoimmunity Panel 6 | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoDOT TORCH IgM | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoWELL HSV 1+2 IgM Test | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoDOT TORCH IgM | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Salmonella typhi | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Herpes Simplex Virus Typing Test | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoDOT TORCH IgM | 2008-08-25 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Mono-M Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Mono-G Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL EBNA IgG Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL EBV VCA IgG Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL EBV VCA IgM Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Rickettsia typhi | 2008-08-24 |
GENBIO [Innominata dba GenBio] | Borrelia DotBlot IgM | 2008-08-24 |
GENBIO [Innominata dba GenBio] | Borrelia DotBlot IgG | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT DNA/ENA Autoimmunity Screening Panel | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Rickettsia Conorii | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Cardiolipin (IgM) Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Cardiolipin (IgG) Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL dsDNA | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Anti SS-B | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Anti-SS-A | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Anti-Sm | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Borrelia Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Borrelia (Lyme) | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL TPO IgG Quantitative Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL Thyroglobulin IgG Quantitative Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Thyroid Autoimmunity Panel | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Autoimmunity Panel 4 | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Rickettsia rickettsii (RMSF) | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT TORCH | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT TORCH | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT TORCH | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT TORCH | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoWELL EBV EA (D) IgG Test | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Leptospira IgM | 2008-08-24 |
GENBIO [Innominata dba GenBio] | ImmunoFA Toxoplasma IgM | 2008-08-22 |
GENBIO [Innominata dba GenBio] | ImmunoFA Toxoplasma IgG | 2008-08-22 |
GENBIO [Innominata dba GenBio] | ImmunoDOT Autoimmunity Panel 1 | 2008-07-10 |
GENBIO [Innominata dba GenBio] | ImmunoFA | 2007-03-28 |
GENBIO [Innominata dba GenBio] | ANA IFA | 2007-03-28 |
GenBio | IMMUNOWELL EA (D) IGG TEST | 2001-06-11 |
GENBIO [Innominata dba GenBio] | ImmunoWELL M. pneumoniae IgG | 1998-12-16 |
GenBio | IMMUNODOT MONO-M TEST | 1998-09-22 |
GenBio | IMMUNODOT MONO-G TEST | 1998-09-22 |
GenBio | IMMUNOWELL EBNA IGG TEST | 1998-08-10 |
GenBio | IMMUNOWELL EBV VCA IGG TEST | 1998-08-10 |
GenBio | IMMUNOWELL VCA IGM TEST | 1998-08-10 |
GenBio | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130) | 1997-05-05 |
GenBio | IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 | 1997-05-02 |
GenBio | MMUNO DOT BORRELIA DOT BLOT M TEST | 1996-05-03 |
GenBio | IMMUNO DOT BORRELIA DOT BLOT G TEST | 1996-05-03 |
GENBIO [Innominata dba GenBio] | ImmunoFA | 1992-11-18 |