IMMUNO CONCEPTS INC

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

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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)

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Colorzyme® nDNA Test System - M7490050001 Catalog Number : 5000

Device Description : nDNA Colorzyme® Bulk Pack - 350 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Colorzyme® nDNA Test System - M7490050051 Catalog Number : 5005

Device Description : nDNA Colorzyme® Bulk Pack - 700 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Colorzyme® nDNA Test System - M7490050401 Catalog Number : 5040

Device Description : nDNA CZ Test System - 70 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Colorzyme® nDNA Test System - M7490052001 Catalog Number : 5200

Device Description : nDNA CZ Test System - 280 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

AUTO I.D.® Sm/RNP Autoantibody Test System - M7490060601 Catalog Number : 6060

Device Description : AUTO I.D.® Sm/RNP Autoantibody - 60 Test System (72 wells)

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Colorzyme® nDNA Test System - M7490080111 Catalog Number : 8011

Device Description : Custom - nDNA Colorzyme® Bulk Pack - 1400 Wells

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490080191 Catalog Number : 8019

Device Description : Custom - ANA FA Slides Only - 100 x 13 Well

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490080601 Catalog Number : 8060

Device Description : Custom - ANA FA Slides Only - 650 x 13 Well

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490080671 Catalog Number : 8067

Device Description : Custom - ANA FA BP - 9000 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent nDNA Test System - M7490081221 Catalog Number : 8122

Device Description : Custom - nDNA FA BP - 4200 wells

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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