FDA Registration
Active
🇺🇸 United States
ARLINGTON SCIENTIFIC, INC.
Reg #: 1641328
·
FEI: 1641328
·
Expires 2026
Products
27
Proprietary Names
59
Establishment Types
3
Classifications
27
Registration Details
- Registration Name
- ARLINGTON SCIENTIFIC, INC.
- Registration Number
- 1641328
- FEI Number
- 1641328
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1840 NORTH TECHNOLOGY DR.
- City
- SPRINGVILLE
- State
- UT
- ZIP
- 84663
- Country
- US
Regulatory Submissions
- 510(k) Number
- BK200488
Owner / Operator
- Firm Name
- ARLINGTON SCIENTIFIC, INC.
- Operator Number
- 1641328
- Address
- 1840 NORTH TECHNOLOGY DR., --
- City
- Springville
- State
- UT
- Postal Code
- 84663
- Country
- US
- Correspondent
- BENJAMIN D CARD
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Antigens, Nontreponemal, All | GMQ | Class 2 | Microbiology | No | 2021-08-11 |
| Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | LGD | Class 2 | Microbiology | No | 2016-02-03 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | Class 1 | Microbiology | No | 2001-10-16 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2001-10-16 |
| Curette, Nasal | KAP | Class 1 | Ear, Nose, Throat | No | 2010-12-16 |
| Enzyme Linked Immunoabsorption Assay, Treponema Pallidum | LIP | Class 2 | Microbiology | No | 2016-02-02 |
| Latex Agglutination Assay, Rubella | LQN | Class 2 | Microbiology | No | 2006-06-01 |
| Chair, Blood Donor | FML | Class 1 | General Hospital | No | 2000-09-22 |
| Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | LGC | Class 2 | Microbiology | No | 2016-02-03 |
| System, Test, Systemic Lupus Erythematosus | DHC | Class 2 | Immunology | No | 2001-10-16 |
| System, Test, Infectious Mononucleosis | KTN | Class 2 | Immunology | No | 2001-10-16 |
| System, Test, Rheumatoid Factor | DHR | Class 2 | Immunology | No | 2001-10-16 |
| Kit, Screening, Staphylococcus Aureus | JWX | Class 1 | Microbiology | No | 2008-01-04 |
| Antisera, Control For Nontreponemal Tests | GMP | Class 2 | Microbiology | No | 2007-12-14 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1 | MXJ | Class 2 | Microbiology | No | 2026-04-03 |
| Pad, Heating, Powered | IRT | Class 2 | Physical Medicine | No | 2011-08-03 |
| Epstein-Barr Virus, Other | LSE | Class 1 | Microbiology | No | 2016-02-03 |
| Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster | LFY | Class 2 | Microbiology | No | 2016-02-02 |
| Enzyme Linked Immunoabsorbent Assay, Rubella | LFX | Class 2 | Microbiology | No | 2016-01-26 |
| Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2 | MYF | Class 2 | Microbiology | No | 2026-04-03 |
| Antibody Igm, If, Epstein-Barr Virus | LJN | Class 1 | Microbiology | No | 2016-02-02 |
| Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | LFZ | Class 2 | Microbiology | No | 2016-02-01 |
| Colorimeter, Photometer, Spectrophotometer For Clinical Use | JJQ | Class 1 | Clinical Chemistry | No | 2016-03-10 |
| Test, Sickle Cell | GHM | Class 2 | Hematology | No | 2006-06-01 |
| Enzyme Linked Immunoabsorbent Assay, Mumps Virus | LJY | Class 1 | Microbiology | No | 2016-02-11 |
| Test, Donor, Syphilis, Antigens, Treponemal | MYR | Class 2 | Microbiology | No | 2006-06-01 |
| Enzyme Linked Immunoabsorbent Assay, Rubeola Igg | LJB | Class 1 | Microbiology | No | 2016-03-10 |
Proprietary Names
ASI Evolution
ASI Toxoplasma IgM EIA Test
ASI ASO SLIDE TEST
CRP SLIDE TEST
ASI ASO Slide Test
ASI RHINO-PRO
ASI Syphilis IgG
Rubella Test Kit
ASI Rubella Test
Cardinal Health Rubella Latex Test
Symetry Lounge
Symetry II Lounge
Innova II Lounge
Duet Mobile Lounge
Parallax Recovery Cot
Symetry Recovery Cot
Space Saver Stationary Lounge
Parallax Lounge
Hampton Lounge
Horizon EL Stationary Lounge
Novax Lounge
ASI HSV IgG EIA Test
Alpha Scientific ANA Latex Test
SLE SLIDE TEST
INFECTIOUS MONONUCLEOSIS TEST
Cardinal Health Color Mono Latex Test
RF DIRECT SLIDE TEST
Cardinal Health RF Latex Test
ASI Staphslide Latex Test
Cardinal Health Staph Latex Test
ASI RPR CARD TEST FOR SYPHILIS
Sure-Vue Signature Raplid Plasma Reagin (RPR) Test Kit
Cardinal Health RPR Card Test for Syphilis
ASI HSV 1 IgG EIA Test
ASI Warming Pad
ASI EB VCA IgG EIA Test
ASI VZV IgG EIA Test
ASI Rubella IgM EIA Test
ASI HSV 2 IgG EIA Test
ASI EB VCA IgM EIA test
ASI CMV IgG EIA Test
ASI Select Staph Test
Sure-Vue Color Staph Test
Biokit Color Staph Test
Biokit Select Staph Test
Sure-Vue Select Staph Test
ASI Color Staph Test
ASI Toxoplasma IgG EIA Test
ASI Infinity Automated EIA Analyzer
SICKLE CELL TEST
ASI Rubella IgG EIA Test
ASI EBNA IgG EIA Test
ASI Synthetic VDRL Antigen Test
ASI Mumps IgM EIA Test
ASI Staph Test
ASI CMV IgM EIA test
ASI Mumps IgG EIA Test
TPHA TEST
ASI Measles IgG EIA Test
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)