Antigens, Nontreponemal, All
Arlington Scientific, Inc.
ARLINGTON SCIENTIFIC, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1641328 | 1641328 | ARLINGTON SCIENTIFIC, INC. | 1 | N | 2026-01-01 | 1840 NORTH TECHNOLOGY DR. SPRINGVILLE UT US 84663 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 32482 | 1120727553 | K993633 | SYNTHETIC VDRL ANTIGEN | GMQ | 2000-02-23 |
| 32482 | 1414211311 | K991975 | SERAQUEST EB NA IGG | LSE | 1999-11-02 |
| 32482 | 1359674939 | K982485 | SERAQUEST CMV IGM | LFZ | 1999-01-13 |
| 32482 | 1274076119 | K982281 | SERAQUEST RUBELLA IGM | LFX | 1998-10-16 |
| 32482 | 1293706658 | K980059 | SERAQUEST MUMPS IGG | LJY | 1998-04-23 |
| 32482 | 1749364618 | K972295 | SERAQUEST VZV IGG | LFY | 1997-11-05 |
| 32482 | 1564140691 | K971672 | SERAQUEST TOXOPLASMA IGM | LGD | 1997-10-21 |
| 32482 | 1648795615 | K963282 | SERAQUEST HSV IGG | LGC | 1997-01-22 |
| 32482 | 1036429392 | K961053 | SERAQUEST RUBELLA IGG | LFX | 1996-09-04 |
| 32482 | 1450503176 | K960947 | SAS SICKLE CELL TEST | GHM | 1996-07-01 |
| 32482 | 2058432565 | K960092 | SERAQUEST TOXOPLASMA IGG | LGD | 1996-06-17 |
| 32482 | 1931382942 | K954191 | SERAQUEST CMV IGG | LFZ | 1996-02-23 |
| 32482 | 1469044907 | K893755 | RUBAGEN | LQN | 1989-08-21 |
| 32482 | 1453220868 | K874019 | STAPHSLIDE | JWX | 1987-10-28 |
| 32482 | 1356965882 | K870625 | IVT SOUTHWEST ALLERGY SCREEN | DHB | 1987-05-01 |
| 32482 | 1893400089 | K855220 | V-TREND KIT STAPH LATEX TEST | JWX | 1986-03-03 |
| 32482 | 1707605408 | K853857 | V-TREND ASO PLUS LATEX TEST | GTQ | 1985-10-16 |
| 32482 | 1175286934 | K851504 | VDRL CARBON ANTIGEN TEST S900500, S900250 & S90010 | GMP | 1985-08-19 |
| 32482 | 1070537617 | K830783 | VERI-STAPH | JWX | 1983-04-08 |
| 32482 | 1688845534 | K821388 | SERO/TEX CRP TEST | DCN | 1982-07-02 |
| 32482 | 1242764992 | K821386 | SERO/TEX MONO TEST | KTN | 1982-07-02 |
| 32482 | 1644888436 | K821385 | SERO/TEX LE TEST | DHC | 1982-05-28 |
| 32482 | 2038071808 | K821319 | SERO/TEX RF TEST | DHR | 1982-05-21 |
| 32482 | 1410592454 | K201438 | ASI Automated RPR (rapid plasma reagin) Test for Syphilis, for use on the ASI Evolution Automated Syphilis Analyzer | GMQ | 2020-10-21 |
| 32482 | 1535097449 | K162276 | SeraQuest Herpes Type 1 Specific IgG | MXJ | 2016-10-01 |
| 32482 | 1761553405 | K152353 | SeraQuest HSV Type 2 Specific IgG | MYF | 2016-05-13 |
| 32482 | 1003715190 | K111356 | ASIMANAGER - AT | JQT | 2011-11-09 |
| 32482 | 1050283748 | K050590 | ENZY-WELL SYPHILIS IGG, MODEL 91106 | LIP | 2006-08-10 |
| 32482 | 1718219193 | K033915 | MODIFICATION TO SERAQUEST EB VCA IGG | LSE | 2004-01-16 |
| 32482 | 1777012849 | K033780 | MODIFICATION TO SERAQUEST VCA IGM | LJN | 2004-01-15 |
| 32482 | 1730925267 | K031490 | RUBELLACOL | LQN | 2003-07-16 |
| 32482 | 1181034458 | BK200539 | |||
| 32482 | 1684057763 | BK200488 | |||
| 32482 | 1074819096 | BK170114 | |||
| 32482 | 1354584250 | BK020031 | |||
| 32482 | 1663282750 | ||||
| 32482 | 1760582404 | ||||
| 32482 | 1007661856 | ||||
| 32482 | 1166788389 | ||||
| 32482 | 1294673722 | ||||
| 32482 | 1569056968 | ||||
| 32482 | 1573400476 | ||||
| 32482 | 1600810186 | ||||
| 32482 | 1932967314 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JWX | 3 | 1987-10-28 |
| GMQ | 2 | 2020-10-21 |
| LSE | 2 | 2004-01-16 |
| LQN | 2 | 2003-07-16 |
| LFZ | 2 | 1999-01-13 |
| LFX | 2 | 1998-10-16 |
| LGD | 2 | 1997-10-21 |
| MXJ | 1 | 2016-10-01 |
| MYF | 1 | 2016-05-13 |
| JQT | 1 | 2011-11-09 |
| LIP | 1 | 2006-08-10 |
| LJN | 1 | 2004-01-15 |
| LJY | 1 | 1998-04-23 |
| LFY | 1 | 1997-11-05 |
| LGC | 1 | 1997-01-22 |
| GHM | 1 | 1996-07-01 |
| DHB | 1 | 1987-05-01 |
| GTQ | 1 | 1985-10-16 |
| GMP | 1 | 1985-08-19 |
| KTN | 1 | 1982-07-02 |
| DCN | 1 | 1982-07-02 |
| DHC | 1 | 1982-05-28 |
| DHR | 1 | 1982-05-21 |
PMN#
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Arlington Scientific, Inc.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Arlington Scientific, Inc.
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
Arlington Scientific, Inc.
ASIMANAGER - AT
ARLINGTON SCIENTIFIC, INC.
Test, Syphilis, Treponema (FOR DONOR TESTING)
Arlington Scientific, Inc.
GUDID#
ASI Evolution - Automated RPR Analyzer.
2023-12-19
ASI RPR Test for Syphilis for Use on the ASI Evolution - Syphilis Screening Test for Use on the ASI Evolution analyzer. 480 test kit
2023-12-19
ASI RPR Test for Syphilis for Use on the ASI Evolution - Syphilis Screening Test for Use on the ASI Evolution Analyzer. 4800 test kit
2023-12-19
ASI RPR Automated Control Set - RPR Control Set for use on the ASI Evolution Analyzer. 2.5 ml each of reactive, weak reactive and nonreactive controls.
2023-12-19
ASI RPR Automated Control Set - RPR Control Set for use on the ASI Evolution Analyzer. 5.0 ml each of reactive, weak reactive and nonreactive controls
2023-12-19
ASI Evolution RPR Titration Diluent - RPR Sample Diluent used on the ASI Evolution Analyzer for performing sample titrations. 25 ml
2023-12-19
ASI RPR Card Test for Syphilis - Syphilis Screening Test with reactive and nonreactive controls. 100 test kit
2023-12-19
ASI RPR Card Test for Syphilis - Syphilis Screening Test with reactive and nonreactive controls. 500 test kit
2023-12-19
ASI Color Staph Latex Test - ASI Color Staph Latex Test 50 test kit
2023-12-19
ASI Color Staph Latex Test - A color enhanced latex agglutination test for the detection of coagulase associated with Staph aureus.
2023-12-19
ASI Color Staph Latex Test - Color Enhanced latex agglutination test for the detection of coagulase associated with Staph aureus
2023-12-19
ASI Rubella Test - Detection of Rubella Virus Antibodies
2016-07-08
ASI Rubella Test - Detection of Rubella Virus Antibodies, Export
2016-07-08
ASI Rubella Test - Detection of Rubella Virus Antibodies
2016-07-08
ASI Rubella Test - Detection of Rubella Virus Antibodies, Export
2016-07-08
ASI Rubella Test - Detection of Rubella Virus Antibodies
2016-07-08
ASI Rubella Test - Detection of Rubella Virus Antibodies, Export
2016-07-08
ASiManager-AT - Semi-automated reader for RPR testomg
2016-07-08
ASI Infinity Analyzer - EIA microtiter plate analyzer
2016-07-08
ASI CRP Control Set - Detection of C-Reactive Protein
2016-07-08
ASI EB VCA IgG EIA Test - Detection of Epstein Barr Viral Capsid Antigen
2016-07-08
ASI EB VCA IgM EIA Test - Detection of Epstein Barr Viral Capsid Antigen
2016-07-08
ASI Staphslide Test - Detection of coagulase associated with Staph aureus
2016-07-08
ASI Staphslide Test - Detection of coagulase associated with Staph. aureus, Export
2016-07-08
ASI Staphslide Test - Detection of coagulase associated with Staph. aureus
2016-07-08
ASI Staphslide Test - Detection of coagulase associated with Staph. aureus, Export
2016-07-08
ASI Staphslide Test - Detection of coagulase associated with Staph. aureus
2016-07-08
ASI Staphslide Test - Detection of coagulase associated with Staph. aureus, Export
2016-07-08
ASI ASO Slide Test - Detection of Anti-Streptolysin O
2016-07-08
ASI ASO Slide Test - Detection of Anti-Strptolysin-O, Export
2016-07-08
ASI ASO Slide Test - Detection of Anti-Streptolysin-O
2016-07-08
ASI ASO Slide Test - Detection of Anti-Streptolysin-O, Export
2016-07-08
ASI ASO Slide Test - Detection of Anti-Streptolysin-O
2016-07-08
ASI ASO Slide Test - Detection of Anti-Streptolysin-O, Export
2016-07-08
ASI ASO Slide Test - Detection of Anti-Streptolysin-O
2016-07-08
ASI SLE Slide Test - Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
2016-07-08
ASI SLE Slide Test - Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export
2016-07-08
ASI SLE Slide Test - Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
2016-07-08
ASI SLE Slide Test - Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export
2016-07-08
ASI SLE Slide Test - Detection of Anti-DNP, associated with Systemic Lupus Erythematosus
2016-07-08