Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1641328

FEI Number

1641328

Entity Name

ARLINGTON SCIENTIFIC, INC.

City/State/Country

SPRINGVILLE, UT, US

Establishment Address

1840 NORTH TECHNOLOGY DR., SPRINGVILLE, UT 84663, US

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

ARLINGTON SCIENTIFIC, INC. (Owner Number: 1641328)

Owner / Operator Contact Address

1840 NORTH TECHNOLOGY DR., --, Springville, UT 84663, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K960947

PMA Number

N/A

All Registered Proprietary Names

ASI Evolution ASI Toxoplasma IgM EIA Test ASI ASO SLIDE TEST ASI Evolution 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 Evolution 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2021-08-11
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2016-02-03
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2001-10-16
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2021-01-21
DCN	System, Test, C-Reactive Protein	Immunology	Class 2	866.5270	2001-10-16
GTQ	Antistreptolysin - Titer/Streptolysin O Reagent	Microbiology	Class 1	866.3720	2009-12-07
KAP	Curette, Nasal	Ear, Nose, Throat	Class 1	874.4420	2010-12-16
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2016-02-02
LQN	Latex Agglutination Assay, Rubella	Microbiology	Class 2	866.3510	2006-06-01
LQN	Latex Agglutination Assay, Rubella	Microbiology	Class 2	866.3510	2007-11-05
FML	Chair, Blood Donor	General Hospital	Class 1	880.6140	2000-09-22
LGC	Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	Microbiology	Class 2	866.3305	2016-02-03
DHC	System, Test, Systemic Lupus Erythematosus	Immunology	Class 2	866.5820	2001-10-16
KTN	System, Test, Infectious Mononucleosis	Immunology	Class 2	866.5640	2001-10-16
DHR	System, Test, Rheumatoid Factor	Immunology	Class 2	866.5775	2001-10-16
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2008-01-04
GMP	Antisera, Control For Nontreponemal Tests	Microbiology	Class 2	866.3820	2007-12-14
MXJ	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-1	Microbiology	Class 2	866.3305	2026-04-03
IRT	Pad, Heating, Powered	Physical Medicine	Class 2	890.5740	2011-08-03
LSE	Epstein-Barr Virus, Other	Microbiology	Class 1	866.3235	2016-02-03
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2016-02-02
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2016-01-26
MYF	Enzyme Linked Immunosorbent Assay, Herpes Simplex Virus, Hsv-2	Microbiology	Class 2	866.3305	2026-04-03
LJN	Antibody Igm, If, Epstein-Barr Virus	Microbiology	Class 1	866.3235	2016-02-02
GMQ	Antigens, Nontreponemal, All	Microbiology	Class 2	866.3820	2021-08-11
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2016-02-01
JWX	Kit, Screening, Staphylococcus Aureus	Microbiology	Class 1	866.2660	2019-05-15
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2016-02-01
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2016-03-10
GHM	Test, Sickle Cell	Hematology	Class 2	864.7825	2006-06-01

Official Correspondent

BENJAMIN CARD

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ARLINGTON SCIENTIFIC, INC.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K954575	Abbott Laboratories	AXSYM TOXO IGG ANTIBODY ASSAY	1996-08-16
K032162	Beckman Coulter, Inc.	ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY	2003-08-08
K760096	Gamma Biologicals, Inc.	REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O	1976-08-03
K083412	Mitsubishi Kagaku Iatron	PATHFAST HSCRP	2009-03-09
K930247	The Binding Site, Ltd.	HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE	1993-03-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-2013	Beckman Coulter Inc.	2	IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) Reagent, PN 447070 The IMMAGE Immunochemistry Systems Rheumatoid Factor (RF) reagent, in conjunction with Beckman Cal 5 Plus, is intended for use in the quantitative determination of human rheumatoid factor concentrations in human serum and plasma samples by rate nephelometry. This assay is designed for use with the IMMAGE Immunochemistry System.
Z-0081-2017	Siemens Healthcare Diagnostics, Inc.	2	SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Z-0082-2017	Siemens Healthcare Diagnostics, Inc.	2	SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age

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2242436	ZEUS SCIENTIFIC LLC	BRANCHBURG, NJ, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1641328. Last updated year: 2026. Please use registration number 1641328 when referencing this establishment in official correspondence.