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

Kit, Screening, Staphylococcus Aureus (JWX) (4) Test, Sickle Cell (GHM) (4) Colorimeter, Photometer, Spectrophotometer For Clinical Use (JJQ) (1) Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica (JQT) (1)

Premarket Exempt

No Yes

Clear

ASI Sickle Cell Test - 00816057020003 Catalog Number : NC-200025

Device Description : Detection of presence of Hgb-S

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GHM

Prescription Use : No

Device Count : 1

ASI Sickle Cell Test - 00816057020010 Catalog Number : NC-200025E

Device Description : Detection of the presence of Hgb-S for Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GHM

Prescription Use : No

Device Count : 1

ASI Sickle Cell Test - 00816057020027 Catalog Number : NC-200100

Device Description : Detection of the presence of Hgb-S

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GHM

Prescription Use : No

Device Count : 1

ASI Sickle Cell Test - 00816057020034 Catalog Number : NC-200100E

Device Description : Detection of the presence of Hgb-S, Export

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GHM

Prescription Use : No

Device Count : 1

ASiManager-AT - 00816057020041 Catalog Number : NC-2400-0BT

Device Description : Semi-automated reader for RPR testomg

Device Class : 1

Duns Number: 785966607

Premarket Exempt : No

Product Code : JQT

Prescription Use : No

Device Count : 1

ASI Infinity Analyzer - 00816057020058 Catalog Number : NC-2700-000

Device Description : EIA microtiter plate analyzer

Device Class : 1

Duns Number: 785966607

Premarket Exempt : Yes

Product Code : JJQ

Prescription Use : No

Device Count : 1

ASI Staphslide Test - 00816057020065 Catalog Number : NC-280-2-25C

Device Description : Detection of coagulase associated with Staph aureus

Device Class : 1

Duns Number: 785966607

Premarket Exempt : No

Product Code : JWX

Prescription Use : No

Device Count : 1

ASI Staphslide Test - 00816057020072 Catalog Number : NC-280-2-25CE

Device Description : Detection of coagulase associated with Staph. aureus, Export

Device Class : 1

Duns Number: 785966607

Premarket Exempt : No

Product Code : JWX

Prescription Use : No

Device Count : 1

ASI Staphslide Test - 00816057020089 Catalog Number : NC-280-2-50C

Device Description : Detection of coagulase associated with Staph. aureus

Device Class : 1

Duns Number: 785966607

Premarket Exempt : No

Product Code : JWX

Prescription Use : No

Device Count : 1

ASI Staphslide Test - 00816057020096 Catalog Number : NC-280-2-50CE

Device Description : Detection of coagulase associated with Staph. aureus, Export

Device Class : 1

Duns Number: 785966607

Premarket Exempt : No

Product Code : JWX

Prescription Use : No

Device Count : 1

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