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

System, Test, C-Reactive Protein (DCN) (7) System, Test, Infectious Mononucleosis (KTN) (3)

Premarket Exempt

No Yes

Clear

ASI Color Mono II Test - 00816057020300 Catalog Number : NC-450100

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 - 00816057020317 Catalog Number : NC-450100E

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 - 00816057020324 Catalog Number : NC-4501000

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 CRP Slide Test - 00816057020331 Catalog Number : NC-500025

Device Description : Detection of C-Reactive Protein

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DCN

Prescription Use : No

Device Count : 1

ASI CRP Slide Test - 00816057020348 Catalog Number : NC-500025E

Device Description : Detection of C-Reactive Protein, Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DCN

Prescription Use : No

Device Count : 1

ASI CRP Slide Test - 00816057020355 Catalog Number : NC-500050

Device Description : Detection of C-Reactive Protein

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DCN

Prescription Use : No

Device Count : 1

ASI CRP Slide Test - 00816057020362 Catalog Number : NC-500050E

Device Description : Detection of C-Reactive Protein, Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DCN

Prescription Use : No

Device Count : 1

ASI CRP Slide Test - 00816057020379 Catalog Number : NC-500100

Device Description : Detection of C-Reactive Protein

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DCN

Prescription Use : No

Device Count : 1

ASI CRP Slide Test - 00816057020386 Catalog Number : NC-500100E

Device Description : Detection of C-Reactive Protein, Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DCN

Prescription Use : No

Device Count : 1

ASI CRP Slide Test - 00816057020393 Catalog Number : NC-5001000

Device Description : Detection of C-Reactive Protein

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DCN

Prescription Use : No

Device Count : 1

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