ARLINGTON SCIENTIFIC, INC.

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

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii (LGD) (2) Enzyme Linked Immunoabsorbent Assay, Rubella (LFX) (2) Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus (LFZ) (2) System, Test, Rheumatoid Factor (DHR) (1) Enzyme Linked Immunoabsorbent Assay, Rubeola Igg (LJB) (1) Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific (LGC) (1) Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster (LFY) (1)

Premarket Exempt

No Yes

Clear

ASI RF Direct Slide Test - 00816057020508 Catalog Number : NC-70010000DC

Device Description : Detection of Rheumatoid Factor

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DHR

Prescription Use : No

Device Count : 1

ASI Rubella IgG EIA Test - 00816057020515 Catalog Number : NC-800096-AG

Device Description : Detection of Rubella Virus Antiboby

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : LFX

Prescription Use : No

Device Count : 1

ASI Rubella IgM EIA Test - 00816057020522 Catalog Number : NC-800096-AM

Device Description : Detection of Rubella Virus Antibody

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : LFX

Prescription Use : No

Device Count : 1

ASI Toxoplasma IgG EIA Test - 00816057020539 Catalog Number : NC-810096-AG

Device Description : Detection of Toxoplasma Antibody

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : LGD

Prescription Use : No

Device Count : 1

ASI Toxoplasma IgM EIA Test - 00816057020546 Catalog Number : NC-810096-AM

Device Description : Detection of Toxoplasma Antibody

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : LGD

Prescription Use : No

Device Count : 1

ASI CMV IgG EIA Test - 00816057020553 Catalog Number : NC-820096-AG

Device Description : Detection of CMV Antibody

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : LFZ

Prescription Use : No

Device Count : 1

ASI CMV IgM EIA Test - 00816057020560 Catalog Number : NC-820096-AM

Device Description : Detection of CMV Antibody

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : LFZ

Prescription Use : No

Device Count : 1

ASI HSV IgG EIA Test - 00816057020577 Catalog Number : NC-830096-AG

Device Description : Detection of Herpes Simplex 1 and 2 Antibodies

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : LGC

Prescription Use : No

Device Count : 1

ASI VZV IgG EIA Test - 00816057020584 Catalog Number : NC-840096-AG

Device Description : Detection of Varicella Zoster Antibody

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : LFY

Prescription Use : No

Device Count : 1

ASI Measles IgG EIA Test - 00816057020591 Catalog Number : NC-850096-AG

Device Description : Detection of Measles Antibody

Device Class : 1

Duns Number: 785966607

Premarket Exempt : Yes

Product Code : LJB

Prescription Use : No

Device Count : 1

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