ARLINGTON SCIENTIFIC, INC.

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

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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

Antisera, Control For Nontreponemal Tests (GMP) (4) Epstein-Barr Virus, Other (LSE) (2) Antibody Igm, If, Epstein-Barr Virus (LJN) (1) Enzyme Linked Immunoabsorbent Assay, Mumps Virus (LJY) (1) Enzyme Linked Immunoabsorbent Assay, Rubeola Igm (PCL) (1)

Premarket Exempt

No Yes

Clear

ASI Measles IgM EIA Test - 00816057020607 Catalog Number : NC-850096-AM

Device Description : Detection of Measles Antibody

Device Class : 1

Duns Number: 785966607

Premarket Exempt : Yes

Product Code : PCL

Prescription Use : No

Device Count : 1

ASI Mumps IgG EIA Test - 00816057020614 Catalog Number : NC-860096-AG

Device Description : Detection of Mumps antibody

Device Class : 1

Duns Number: 785966607

Premarket Exempt : No

Product Code : LJY

Prescription Use : No

Device Count : 1

ASI Mumps IgM EIA Test - 00816057020621 Catalog Number : NC-860096-AM

Device Description : Detection of Mumps Antibody

Device Class :

Duns Number: 785966607

Premarket Exempt : Yes

Product Code :

Prescription Use : No

Device Count : 1

ASI EBNA IgG EIA Test - 00816057020638 Catalog Number : NC-870096-AG

Device Description : Detection of Epstein Barr Nuclear Antigen

Device Class : 1

Duns Number: 785966607

Premarket Exempt : No

Product Code : LSE

Prescription Use : No

Device Count : 1

ASI EB VCA IgG EIA Test - 00816057020645 Catalog Number : NC-880096-AG

Device Description : Detection of Epstein Barr Viral Capsid Antigen

Device Class : 1

Duns Number: 785966607

Premarket Exempt : No

Product Code : LSE

Prescription Use : No

Device Count : 1

ASI EB VCA IgM EIA Test - 00816057020652 Catalog Number : NC-880096-AM

Device Description : Detection of Epstein Barr Viral Capsid Antigen

Device Class : 1

Duns Number: 785966607

Premarket Exempt : No

Product Code : LJN

Prescription Use : No

Device Count : 1

ASI RPR Card Test for Syphilis - 00816057020690 Catalog Number : NC-900025

Device Description : Syphilis Screening Test

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GMP

Prescription Use : No

Device Count : 1

ASI RPR Card Test for Syphilis - 00816057020706 Catalog Number : NC-900025E

Device Description : Syphilis Screening Test, Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GMP

Prescription Use : No

Device Count : 1

ASI RPR Card Test for Syphilis - 00816057020713 Catalog Number : NC-900100

Device Description : Detection of Syphilis

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GMP

Prescription Use : No

Device Count : 1

ASI RPR Card Test for Syphilis - 00816057020720 Catalog Number : NC900100-FD

Device Description : Detection of Syphilis, Export (French)

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GMP

Prescription Use : No

Device Count : 1

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