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

System, Test, Systemic Lupus Erythematosus (DHC) (6) System, Test, Infectious Mononucleosis (KTN) (4)

Premarket Exempt

No Yes

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ASI SLE Slide Test - 00816057020201 Catalog Number : NC-350025E

Device Description : Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DHC

Prescription Use : No

Device Count : 1

ASI SLE Slide Test - 00816057020218 Catalog Number : NC-350050

Device Description : Detection of Anti-DNP, associated with Systemic Lupus Erythematosus

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DHC

Prescription Use : No

Device Count : 1

ASI SLE Slide Test - 00816057020225 Catalog Number : NC-350050E

Device Description : Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DHC

Prescription Use : No

Device Count : 1

ASI SLE Slide Test - 00816057020232 Catalog Number : NC-350100

Device Description : Detection of Anti-DNP, associated with Systemic Lupus Erythematosus

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DHC

Prescription Use : No

Device Count : 1

ASI SLE Slide Test - 00816057020249 Catalog Number : NC350100E

Device Description : Detection of Anti-DNP, associated with Systemic Lupus Erythematosus, Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DHC

Prescription Use : No

Device Count : 1

ASI SLE Slide Test - 00816057020256 Catalog Number : NC-3501000

Device Description : Detection of Anti-DNP, associated with Systemic Lupus Erythematosus

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DHC

Prescription Use : No

Device Count : 1

ASI Color Mono II Test - 00816057020263 Catalog Number : NC-450025

Device Description : Detection of heterophil antibodies associated with infectious mononucleosis

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : KTN

Prescription Use : No

Device Count : 1

ASI Color Mono II Test - 00816057020270 Catalog Number : NC-450025E

Device Description : Detection of heterophil antibodies associated with infectious mononucleosis, Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : KTN

Prescription Use : No

Device Count : 1

ASI Color Mono II Test - 00816057020287 Catalog Number : NC-450050

Device Description : Detection of heterophil antibodies associated with infectious mononucleosis

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : KTN

Prescription Use : No

Device Count : 1

ASI Color Mono II Test - 00816057020294 Catalog Number : NC-450050E

Device Description : Detection of heterophil antibodies associated with infectious mononucleosis, Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : KTN

Prescription Use : No

Device Count : 1

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