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

Antisera, Control For Nontreponemal Tests (GMP) (6) Anti-Streptokinase (GTO) (1) Kit, Screening, Staphylococcus Aureus (JWX) (1) System, Test, Infectious Mononucleosis (KTN) (1) System, Test, Systemic Lupus Erythematosus (DHC) (1)

Premarket Exempt

No Yes

Clear

ASI RPR Disposible Test Cards - 00816057021376 Catalog Number : NC-906030-25

Device Description : Detection of Syphilis, 25 - 30 well

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GMP

Prescription Use : No

Device Count : 1

ASI RPR Disposible Test Card - 00816057021383 Catalog Number : NC-906030-B

Device Description : Detection of Syphilis, 1500 - 30 well

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GMP

Prescription Use : No

Device Count : 1

ASI RPR Disposible Test Cards - 00816057021390 Catalog Number : NC-906030-G

Device Description : Detection of Syphilis, 25 - 30, generic

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GMP

Prescription Use : No

Device Count : 1

ASI RPR Disposible Test Cards - 00816057021406 Catalog Number : NC-9871010

Device Description : Detection of Syphilis, 300 - 10 well

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GMP

Prescription Use : No

Device Count : 1

ASI RPR Disposible Test Card - 00816057021413 Catalog Number : NC-987015

Device Description : Detection of Syphilis, 300 - 15 well

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GMP

Prescription Use : No

Device Count : 1

ASI DIsposible Test Card - 00816057021420 Catalog Number : NC-987030

Device Description : Detection of Syphilis, 100 - 30 well

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : GMP

Prescription Use : No

Device Count : 1

ASI Staphslide Control Set - 00816057021581 Catalog Number : NC-285001

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 ASO Control Set - 00816057021598 Catalog Number : NC-305001

Device Description : Detection of Anti-Streptolysin-O

Device Class : 1

Duns Number: 785966607

Premarket Exempt : No

Product Code : GTO

Prescription Use : No

Device Count : 1

ASI SLE Slide Test Control Set - 00816057021604 Catalog Number : NC355001

Device Description : Detection of Asnti-DNP, associated with Systemis Lupus Erythematosus

Device Class : 2

Duns Number: 785966607

Premarket Exempt : No

Product Code : DHC

Prescription Use : No

Device Count : 1

ASI Color Mono II Control Set - 00816057021611 Catalog Number : NC-455001

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

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