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 | NGS-Turbo® demo kit Amp+Prep (2) | 2026-01-05 |
| Genbio | NGSgo®-MX6-1 Multiplex A, B, C, DRB1, DQB1, DPB1 (96) RUO | 2026-01-05 |
| Genbio | NGSgo®-AmpX v2 HLA-DQA1 (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v2 HLA-DRB1 (96) | 2026-01-05 |
| Genbio | NGSgo-AmpX v2 HLA-DRB1 Whole Gene (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v2 HLA-DQB1 (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v2 HLA-DQB1 Whole Gene (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v2 HLA-DPB1 (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v2 HLA-C (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v2 HLA-B (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v2 HLA-A (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v3 HLA-DQA1 (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v3 HLA-DRB1 (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v3 HLA-DQB1 (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v3 HLA-C (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v3 HLA-B (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX v3 HLA-A (96) | 2026-01-05 |
| Genbio | NGSgo®-LibrX Illumina Library Preparation Kit (96) | 2026-01-05 |
| Genbio | NGSgo®-AmpX MICA,MICB (96) | 2026-01-05 |
| Genbio | GenDx-AMPure XP - AMPure beads and elution buffer (5 ml) | 2026-01-05 |
| Genbio | NGSgo-IndX Illumina Adapter & Indices plate IV (96) | 2026-01-05 |
| Genbio | NGSgo-IndX Illumina Adapter & Indices plate III (96) | 2026-01-05 |
| Genbio | NGSgo-IndX Illumina Adapter & Indices plate II (96) | 2026-01-05 |
| Genbio | NGSgo-IndX Illumina Adapter & Indices plate I (96) | 2026-01-05 |
| Genbio | HLA-KMR marker KMR522-DPB1 (12) | 2026-01-05 |
| Genbio | HLA-KMR marker KMR521-DPB1 (12) | 2026-01-05 |
| Genbio | HLA-KMR marker KMR520-DPB1 (12) | 2026-01-05 |
| Genbio | HLA-KMR marker KMR512-C (12) | 2026-01-05 |
| Genbio | HLA-KMR marker KMR511-C (12) | 2026-01-05 |
| Genbio | HLA-KMR marker KMR506-A (12) | 2026-01-05 |
| Genbio | HLA-KMR marker KMR505-A (12) | 2026-01-05 |
| Genbio | HLA-KMR marker KMR504-A (12) | 2026-01-05 |
| Genbio | HLA-KMR marker KMR502-A (12) | 2026-01-05 |
| Genbio | HLA-KMR marker KMR501-A (12) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR057 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR056 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR055 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR054 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR053 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR052 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR051 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR050 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR049 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR048 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR047 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR046 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR045 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR044 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR043 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR042 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR041 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR040 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR039 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR038 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR037 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR036 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR034 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR033 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR031 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR030 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR029 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR028 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR020 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR019 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR017 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR016 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR014 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR013 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR011 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR010 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR009 (48) | 2026-01-05 |
| Genbio | KMRtrack Monitoring marker KMR004 (48) | 2026-01-05 |
| Genbio | KMRassay Reference Assay 901 REF901 (288) | 2026-01-05 |
| Genbio | KMRassay qPCR Buffer & Enzyme (288) | 2026-01-05 |
| Genbio | KMRtype Genotyping markers Extended kit (24) | 2026-01-05 |
| Genbio | KMRtype Genotyping markers Core kit (24) | 2026-01-05 |
| Genbio | KMRengine Chimerism monitoring software One year extension | 2026-01-05 |
| Genbio | AlleleSEQR® HLA-DPB1 PCR/Sequencing kit (25) | 2026-01-05 |
| Genbio | AlleleSEQR® HLA-DQB1 PCR/Sequencing kit (25) | 2026-01-05 |
| Genbio | AlleleSEQR® HLA-DRB1 PCR/Sequencing kit (25) | 2026-01-05 |
| Genbio | AlleleSEQR® HLA-C PCR/Sequencing kit (25) | 2026-01-05 |
| Genbio | AlleleSEQR® HLA-B PCR/Sequencing kit (25) | 2026-01-05 |
| Genbio | AlleleSEQR® HLA-A PCR/Sequencing kit (25) G-8344342-44 | 2026-01-05 |
| Genbio | NGSgo-IndX Plate I (Indices Illumina) | 2026-01-05 |
| Genbio | NGSgo-AmpX v2 HLA-B | 2026-01-05 |
| Genbio | NGSgo-IndX Plate IV | 2026-01-05 |
| Genbio | NGSgo-IndX Plate II | 2026-01-05 |
| Genbio | NGSgo-IndX Plate III | 2026-01-05 |
| Genbio | Nuclease-Free Water G-8344342-44 | 2026-01-05 |
| Genbio | GenDx-LongMix | 2026-01-05 |
| Genbio | NGSgo Library Full Kit for Illumina IndX plate II | 2026-01-05 |
| Genbio | NGSgo ProntoPrep HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96) | 2026-01-05 |
| Genbio | NGSgo ProntoAmp HLA-A, B, C, DRB1, DQB1, DPB1, DRB3/4/5, DQA1, DPA1 (96) | 2026-01-05 |
| Genbio | NGS-TurboPrep Library preparation for ONT(12) | 2026-01-05 |
| Genbio | NGSgo-MX11-3 | 2026-01-05 |
| Genbio | NGS-TurboAmp Multiplex 11 loci for ONT (12) | 2026-01-05 |
| Genbio | NGSgo Library Full Kit for Illumina IndX Plate I | 2026-01-05 |
| Genbio | NGSgo-AmpX v2 HLA GeneSuite | 2026-01-05 |
| Genbio | NGSgo Library Full Kit for Illumina IndX Plate IV | 2026-01-05 |
| Genbio | NGSgo Library Full Kit for Illumina IndX Plate III | 2026-01-05 |
GENBIO [Innominata dba GenBio] | CorneaCold | 2019-08-14 |
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 |