Data / Medical devices / United States / Arlington Scientific, Inc.
Arlington Scientific, Inc.: FDA-registered device maker in Springville, UT, United States, 29 510(k) clearances
Arlington Scientific, Inc. is registered with the FDA (registration 1641328) in Springville, UT, United States. It lists 27 device types. The FDA files 29 510(k) clearances under its listings, the newest dated October 21, 2020. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 1641328
- Address
- 1840 North Technology DR., Springville, UT, United States, 84663
- Owner or operator
- ARLINGTON SCIENTIFIC, INC. (1641328)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- September 22, 2000
- Registered through
- 2027
- Brand names listed
- ASI ASO SLIDE TEST, ASI ASO Slide Test, ASI CMV IgG EIA Test, ASI CMV IgM EIA test, ASI Color Staph Test, ASI EB VCA IgG EIA Test, ASI EB VCA IgM EIA test, ASI EBNA IgG EIA Test and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| October 21, 2020 | K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer | GMQ | Substantially Equivalent | Arlington Scientific, Inc. (Asi) | accessdata.fda.gov |
| October 1, 2016 | K162276 | SeraQuest Herpes Type 1 Specific IgG | MXJ | Substantially Equivalent | Quest International, Inc. | accessdata.fda.gov |
| May 13, 2016 | K152353 | SeraQuest HSV Type 2 Specific IgG | MYF | Substantially Equivalent | Quest International, Inc. | accessdata.fda.gov |
| August 10, 2006 | K050590 | ENZY-WELL SYPHILIS IGG, MODEL 91106 | LIP | Substantially Equivalent | Diesse Diagnostica Senese S.P.A. | accessdata.fda.gov |
| January 16, 2004 | K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | LSE | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| January 15, 2004 | K033780 | MODIFICATION TO SERAQUEST VCA IGM | LJN | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| July 16, 2003 | K031490 | RUBELLACOL | LQN | Substantially Equivalent | Immunostics Inc., | accessdata.fda.gov |
| February 23, 2000 | K993633 | SYNTHETIC VDRL ANTIGEN | GMQ | Substantially Equivalent | Centers for Disease Control and Prevention | accessdata.fda.gov |
| November 2, 1999 | K991975 | SERAQUEST EB NA IGG | LSE | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| January 13, 1999 | K982485 | SERAQUEST CMV IGM | LFZ | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| October 16, 1998 | K982281 | SERAQUEST RUBELLA IGM | LFX | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| April 23, 1998 | K980059 | SERAQUEST MUMPS IGG | LJY | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| November 5, 1997 | K972295 | SERAQUEST VZV IGG | LFY | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| October 21, 1997 | K971672 | SERAQUEST TOXOPLASMA IGM | LGD | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| January 22, 1997 | K963282 | SERAQUEST HSV IGG | LGC | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| September 4, 1996 | K961053 | SERAQUEST RUBELLA IGG | LFX | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| July 1, 1996 | K960947 | SAS SICKLE CELL TEST | GHM | Substantially Equivalent | Sa Scientific, Inc. | accessdata.fda.gov |
| June 17, 1996 | K960092 | SERAQUEST TOXOPLASMA IGG | LGD | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| February 23, 1996 | K954191 | SERAQUEST CMV IGG | LFZ | Substantially Equivalent | Quest Intl., Inc. | accessdata.fda.gov |
| August 21, 1989 | K893755 | RUBAGEN | LQN | Substantially Equivalent | Biokit USA, Inc. | accessdata.fda.gov |
| October 28, 1987 | K874019 | STAPHSLIDE | JWX | Substantially Equivalent | Ncs Diagnostics, Inc. | accessdata.fda.gov |
| March 3, 1986 | K855220 | V-TREND KIT STAPH LATEX TEST | JWX | Substantially Equivalent | Texas Immunology, Inc. | accessdata.fda.gov |
| October 16, 1985 | K853857 | V-TREND ASO PLUS LATEX TEST | GTQ | Substantially Equivalent | Texas Immunology, Inc. | accessdata.fda.gov |
| August 19, 1985 | K851504 | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 | GMP | Substantially Equivalent | Ncs Diagnostics, Inc. | accessdata.fda.gov |
| April 8, 1983 | K830783 | VERI-STAPH | JWX | Substantially Equivalent | Zeus Technologies | accessdata.fda.gov |
| July 2, 1982 | K821388 | SERO/TEX CRP TEST | DCN | Substantially Equivalent | Texas Immunology, Inc. | accessdata.fda.gov |
| July 2, 1982 | K821386 | SERO/TEX MONO TEST | KTN | Substantially Equivalent | Texas Immunology, Inc. | accessdata.fda.gov |
| May 28, 1982 | K821385 | SERO/TEX LE TEST | DHC | Substantially Equivalent | Texas Immunology, Inc. | accessdata.fda.gov |
| May 21, 1982 | K821319 | SERO/TEX RF TEST | DHR | Substantially Equivalent | Texas Immunology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Antistreptolysin - Titer/Streptolysin O Reagent
- All makers of Epstein-Barr Virus, Other
- All makers of Antibody Igm, If, Epstein-Barr Virus
- All makers of Kit, Screening, Staphylococcus Aureus
- All makers of System, Test, C-Reactive Protein
Updated October 21, 2020. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.