Gull Laboratories, Inc.
Medical device manufacturer in Salt Lake City, UT.
57510(k) clearances
0PMA approvals
0recalls
Device types
- LGC Enzyme Linked Immunoabsorbent Assay, Herpes… 7
- LGD Enzyme Linked Immunoabsorbent Assay… 6
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 5
- LFZ Enzyme Linked Immunoabsorbent Assay… 4
- LSE Epstein-Barr Virus, Other 3
- LLM Test, Antigen, Nuclear, Epstein-Barr Virus 2
- GNW Antisera, Cf, Influenza Virus A, B, C 2
- LJB Enzyme Linked Immunoabsorbent Assay… 2
- LKT Respiratory Syncytial Virus, Antigen… 2
- GQX Antiserum, Cf, Varicella-Zoster 2
- GQI Antiserum, Cf, Cytomegalovirus 2
- GLZ Antigens, If, Toxoplasma Gondii 2
- GQL Antisera, Fluorescent, Herpesvirus Hominis… 2
- DHN Antinuclear Antibody, Indirect… 1
- DEW Igg, Antigen, Antiserum, Control 1
- GRE Antiserum, Fluorescent, Rubeola 1
- LKQ Antibody Igm,If, Cytomegalovirus Virus 1
- KTN System, Test, Infectious Mononucleosis 1
- JRY Antiserum, Fluorescent, Epstein-Barr Virus 1
- LJY Enzyme Linked Immunoabsorbent Assay, Mumps… 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K983541 | HSV 1+2 Igg Elisa TestLGC · Traditional | 02/26/1999SE |
| K971857 | Mumps Igg Elisa TestyLJY · Traditional | 11/04/1997SE |
| K962343 | Toxo Igg Elisa TestLGD · Traditional | 03/24/1997SE |
| K935730 | Ebna Igg Elisa TestLLM · Traditional | 09/19/1995SE |
| K940093 | Ebv-Ea(D) Igg Elisa TestLSE · Traditional | 09/15/1995SE |
| K941046 | VZV Igg Elisa TestLFY · Traditional | 08/24/1995SE |
| K941198 | Ebv LGG Elisa TestLSE · Traditional | 08/23/1995SE |
| K932333 | Protectoral Ultrasonic Handpiece ProcessorEFB · Traditional | 08/15/1995SE |
| K941624 | Rubella Igg Elisa TestLFX · Traditional | 08/04/1995SE |
| K922759 | HSV-2 Igm Elisa Test--ModificationLGC · Traditional | 10/05/1992SE |
| K922758 | HSV-1 Igm Elisa Test -- ModificationLGC · Traditional | 10/05/1992SE |
| K911233 | Chagas' Igg Elisa TestMIU · Traditional | 05/04/1992SE |
| K915893 | Rubella Igg Elisa TestLFX · Traditional | 03/04/1992SE |
| K915891 | Toxo Igg Elisa Test (Modified)LGD · Traditional | 03/04/1992SE |
| K915892 | CMV Igg Elisa TestLFZ · Traditional | 02/14/1992SE |
| K913351 | Influenza Mab Test/Influenza a TestGNW · Traditional | 12/17/1991SE |
| K913214 | Influenza Mab Test/Influenza B TestGNW · Traditional | 12/13/1991SE |
| K912842 | Rsv-Mab TestLKT · Traditional | 12/09/1991SE |
| K912592 | Cmv-Ea Mab TestLIN · Traditional | 12/04/1991SE |
| K912558 | Gull ElisawareLIB · Traditional | 09/16/1991SE |
| K911301 | VZV Igm TestGQX · Traditional | 07/17/1991SE |
| K903013 | Lyme Igm Elisa TestLSR · Traditional | 06/21/1991SE |
| K910955 | HSV-1 Igm Elisa TestLGC · Traditional | 05/28/1991SE |
| K910954 | HSV-1 Igg Elisa TestLGC · Traditional | 05/28/1991SE |
| K910953 | HSV-2 Igm Elisa TestLGC · Traditional | 05/28/1991SE |
| K910952 | HSV-2 Igg Elisa TestLGC · Traditional | 05/28/1991SE |
| K910872 | Ebv Igg Elisa TestMCD · Traditional | 04/12/1991SE |
| K910042 | Ebv Igm Elisa TestLJN · Traditional | 02/21/1991SE |
| K904083 | Rubeola Igm Elisa TestLJB · Traditional | 01/03/1991SE |
| K903807 | CMV Igm Elisa TestLFZ · Traditional | 12/17/1990SE |
| K904854 | Rubeola Igg Elisa TestLJB · Traditional | 12/04/1990SE |
| K904084 | Rubella Igm Elisa TestLFX · Traditional | 12/04/1990SE |
| K903324 | Toxo Igm Elisa TestLGD · Traditional | 10/16/1990SE |
| K901635 | Rubella Igg Elisa TestLFX · Traditional | 06/28/1990SE |
| K900796 | CMV Igg Elisa TestLFZ · Traditional | 05/02/1990SE |
| K900354 | Toxo Igg Elisa TestLGD · Traditional | 04/16/1990SE |
| K893230 | Detectadot TM System 2000 CMV Igm TestLFZ · Traditional | 12/18/1989SE |
| K893200 | Detectadot (TM) System 2000 Toxo Igm TestLGD · Traditional | 12/18/1989SE |
| K895891 | Detectadot System 2000 Heterophile TestKTN · Traditional | 10/31/1989SE |
| K892202 | Detectadot(Tm) System 2000 Rubella Igg TestLFX · Traditional | 09/13/1989SE |
| K884004 | Rubeola TestGRE · Traditional | 12/05/1988SE |
| K882687 | Anti-Respiratory Syncytial Virus Antibody TestLKT · Traditional | 08/30/1988SE |
| K875159 | Detectadot System 2000 CMV Igg TestGQI · Traditional | 05/06/1988SE |
| K875358 | VZV TestGQX · Traditional | 03/31/1988SE |
| K880043 | Ebv-Na TestLLM · Traditional | 03/24/1988SE |
| K880007 | Toxo Igm TestGLZ · Traditional | 03/17/1988SE |
| K875109 | Detectadot System 2000 Toxo Igg TestLGD · Traditional | 03/07/1988SE |
| K875254 | Gullsorb Igg Inactivation ReagentDEW · Traditional | 02/17/1988SE |
| K872617 | Ebv-Ea TestLSE · Traditional | 01/05/1988SE |
| K853137 | CMV TestGQI · Traditional | 11/14/1985SE |
| K831711 | CMV Igm TestLKQ · Traditional | 10/27/1983SE |
| K830865 | HSV Igm TestGQL · Traditional | 07/18/1983SE |
| K822734 | Ebv Igm TestJRY · Traditional | 12/09/1982SE |
| K772243 | Toxo TestGLZ · Traditional | 12/22/1977SE |
| K771062 | Ebv TestGNP · Traditional | 07/14/1977SE |
| K771063 | HSV TestGQL · Traditional | 07/11/1977SE |
| K771064 | Ana TestDHN · Traditional | 06/24/1977SE |