SeraQuest Q01-260
GUDID 00850487007487
SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)
QUEST INTERNATIONAL, INC.
SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA)| Primary Device ID | 00850487007487 |
| NIH Device Record Key | 1821afd1-7b00-48cf-8a8c-b8171bc07e34 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | SeraQuest |
| Version Model Number | Anti-SSB |
| Catalog Number | Q01-260 |
| Company DUNS | 883350811 |
| Company Name | QUEST INTERNATIONAL, INC. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | true |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Operating and Storage Conditions
| Storage Environment Temperature | Between 2 Degrees Celsius and 8 Degrees Celsius |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00850487007487 [Primary] |
FDA Product Code
| LLL | Extractable Antinuclear Antibody, Antigen And Control |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 2 |
| Public Version Date | 2018-03-29 |
| Device Publish Date | 2016-08-31 |
On-Brand Devices [SeraQuest]
| 00850487007654 | Helicobacter pylori immunoglobulin A (IgA) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007630 | Multiple extractable nuclear antigen (ENA) IVD, kit, enzyme immunoassay (EIA) |
| 00850487007616 | Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007609 | Treponema pallidum immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007593 | Sm/RNP antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007586 | Mumps virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007579 | Mumps virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007562 | Measles virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007555 | Herpes simplex virus 2 (HSV2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007548 | Herpes simplex virus 1 (HSV1) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007531 | Helicobacter pylori immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007524 | Epstein-Barr virus (EBV) early antigen (EA) immunoglobulin G (IgG) antibody IVD, kit, enzyme imm |
| 00850487007517 | Anticardiolipin antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007500 | Thyroid peroxidase antibody (anti-TPO/microsomal antibody) IVD, kit, enzyme immunoassay (EIA) |
| 00850487007494 | Thyroglobulin antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007487 | SSB/La antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) |
| 00850487007470 | SSA/Ro antibody (Sjogren's antibody) IVD, kit, enzyme immunoassay (EIA) |
| 00850487007463 | Smith antibody (anti-Sm) IVD, kit, enzyme immunoassay (EIA) |
| 00850487007456 | Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA) |
| 00850487007449 | Double stranded DNA antibody (anti-dsDNA) IVD, kit, enzyme immunoassay (EIA) |
| 00850487007432 | Jo-1 antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007425 | Multiple antinuclear antibody (ANA) screening IVD, kit, enzyme immunoassay (EIA) |
| 00850487007418 | Epstein-Barr virus (EBV) VCA immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007401 | Toxoplasma gondii immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007395 | Rubella virus immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007388 | Rubella virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007371 | Epstein-Barr virus (EBV) VCA immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007364 | Epstein-Barr virus nuclear antigen (EBNA) immunoglobulin G (IgG) antibody IVD, kit, enzyme immun |
| 00850487007357 | Measles virus immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007340 | Varicella-zoster virus (VZV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007333 | Herpes simplex virus 1 & 2 (HSV1 & 2) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoass |
| 00850487007326 | Cytomegalovirus (CMV) immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA) |
| 00850487007319 | Cytomegalovirus (CMV) immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA) |
Trademark Results [SeraQuest]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SERAQUEST 78879231 3215661 Live/Registered |
AWARENESS TECHNOLOGY, INCORPORATED 2006-05-09 |
 SERAQUEST 74646211 2044578 Dead/Cancelled |
QUEST INTERNATIONAL, INC. 1995-03-13 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.