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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IMMUNO CONCEPTS - M7490081311 Catalog Number : 8131

Device Description : Custom - EBNA FA BP - 3900 wells

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490081451 Catalog Number : 8145

Device Description : Custom - ANA FA Super Bulk Pack - 4200 Wells

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

RELISA® Cardiolipin IgG & IgM Antibody Test - M7490081921 Catalog Number : 8192

Device Description : Custom - RELISA® Cardiolipin IgG & IgM Bulk Pack - 576 wells

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

IgG Anti-nDNA Fluorescent Test System - M7490081961 Catalog Number : 8196

Device Description : Custom - nDNA IgG Fluorescent Bulk Pack - 700 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

IgG Anti-nDNA Fluorescent Test System - M7490081971 Catalog Number : 8197

Device Description : Custom - nDNA IgG Fluorescent Bulk Pack - 1400 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent nDNA Test System - M7490082271 Catalog Number : 8227

Device Description : Custom- nDNA Fluorescent Bulk Pack - 700 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490082601 Catalog Number : 8260

Device Description : Custom - HEp-2 FA ANA w/cs Super Bulk Pack - 5400 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490082611 Catalog Number : 8261

Device Description : Custom - HEp-2 FA ANA w/cs Super Bulk Pack - 5400 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent nDNA Test System - M7490082681 Catalog Number : 8268

Device Description : Custom - ANA Sample Diluent Bulk Pack - 100 x 100mls

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490082761 Catalog Number : 8276

Device Description : Custom - ANA Sample Diluent Bulk Pack - 100 x 100mls

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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