IMMUNO CONCEPTS INC

Address:2280 Springlake Road,Dallas,TX,75234,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

Premarket Exempt

Clear

Fluorescent ANA Test System - M7490001001 Catalog Number : 100

Device Description : Serum Diluent 2 x 100ml

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

HEp-2000® Fluorescent ANA-Ro Test System - M7490002001 Catalog Number : 200

Device Description : Serum Diluent 4 x 100ml

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490005001 Catalog Number : 500

Device Description : Serum Diluent 2 x 500ml

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490010001 Catalog Number : 1000

Device Description : Serum Diluent 4 x 500ml

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490020001 Catalog Number : 2000

Device Description : ANA Fluorescent Bulk Pack - 1300 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490020031 Catalog Number : 2003

Device Description : ANA Fluorescent Bulk Pack - 1300 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490020041 Catalog Number : 2004

Device Description : ANA Fluorescent Bulk Pack - 1300 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490020051 Catalog Number : 2005

Device Description : ANA Fluorescent Bulk Pack - 650 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

HEp-2000® Fluorescent ANA-Ro Test System - M7490020321 Catalog Number : 2032

Device Description : ANA Control Set - 1 Each of Five Controls

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490020401 Catalog Number : 2040

Device Description : ANA Fluorescent Test System - 70 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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