Quest Intl., Inc.
Medical device manufacturer in Mami, FL.
25510(k) clearances
0PMA approvals
0recalls
Device types
- LSE Epstein-Barr Virus, Other 4
- LYY Latex Patient Examination Glove 2
- LFZ Enzyme Linked Immunoabsorbent Assay… 2
- LGD Enzyme Linked Immunoabsorbent Assay… 2
- LFX Enzyme Linked Immunoabsorbent Assay, Rubella 2
- LKP Anti-Sm Antibody, Antigen And Control 2
- LJN Antibody Igm, If, Epstein-Barr Virus 2
- LGC Enzyme Linked Immunoabsorbent Assay, Herpes… 1
- LFY Enzyme Linked Immunoabsorbent Assay… 1
- LJY Enzyme Linked Immunoabsorbent Assay, Mumps… 1
- LRM Anti-Dna Antibody (Enzyme-Labeled)… 1
- LJM Antinuclear Antibody (Enzyme-Labeled)… 1
- LLL Extractable Antinuclear Antibody, Antigen… 1
- MID System, Test, Anticardiolipin Immunological 1
- DDC Thyroglobulin, Antigen, Antiserum, Control 1
- JZO System, Test, Thyroid Autoantibody 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K091260 | Seraquest Ebv Ea-D Igg TestLSE · Traditional | 06/08/2009SE |
| K033915 | Modification to Seraquest Eb Vca IggLSE · Special | 01/16/2004SE |
| K033780 | Modification to Seraquest Vca IgmLJN · Special | 01/15/2004SE |
| K023593 | Seraquest Anti-Thyroid Peroxidase (Tpo)JZO · Traditional | 02/06/2003SE |
| K023592 | Seraquest Anti-ThyroglobulinDDC · Traditional | 01/06/2003SE |
| K003069 | Anti-Cardiolipin, Multiple Autoantibodies Immunological Test SystemMID · Traditional | 11/27/2000SE |
| K991975 | Seraquest Eb Na IggLSE · Traditional | 11/02/1999SE |
| K990410 | Seraquest Eb Vca IggLSE · Traditional | 10/28/1999SE |
| K990977 | Seraquest Eb Vac IgmLJN · Traditional | 10/06/1999SE |
| K982485 | Seraquest CMV IgmLFZ · Traditional | 01/13/1999SE |
| K982281 | Seraquest Rubella IgmLFX · Traditional | 10/16/1998SE |
| K980639 | Seraquest Anti-SsbLLL · Traditional | 06/15/1998SE |
| K980540 | Seraquest Anti-SmLKP · Traditional | 06/15/1998SE |
| K980811 | Seraquest Anti-Sm/RnpLKP · Traditional | 05/12/1998SE |
| K980810 | Seraquest Anti-SsaLJM · Traditional | 05/12/1998SE |
| K980391 | Seraquest Anti-DsdnaLRM · Traditional | 04/24/1998SE |
| K980059 | Seraquest Mumps IggLJY · Traditional | 04/23/1998SE |
| K972295 | Seraquest VZV IggLFY · Traditional | 11/05/1997SE |
| K971672 | Seraquest Toxoplasma IgmLGD · Traditional | 10/21/1997SE |
| K963282 | Seraquest HSV IggLGC · Traditional | 01/22/1997SE |
| K961053 | Seraquest Rubella IggLFX · Traditional | 09/04/1996SE |
| K960092 | Seraquest Toxoplasma IggLGD · Traditional | 06/17/1996SE |
| K954191 | Seraquest CMV IggLFZ · Traditional | 02/23/1996SE |
| K891736 | Patient Examination Gloves (Latex)LYY · Traditional | 05/25/1989SE |
| K890356 | Latex Examination Gloves Non-SterileLYY · Traditional | 04/06/1989SE |