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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IgG Anti-nDNA Fluorescent Test System - M7490082841 Catalog Number : 8284

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

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

IgG Anti-nDNA Fluorescent Test System - M7490082871 Catalog Number : 8287

Device Description : Custom - IgG anti-nDNA Fluorescent Bulk Pack - 350 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

RELISA® Cardiolipin IgG & IgM Antibody Test - M7490082881 Catalog Number : 8288

Device Description : Custom RELISA® BP- Cardiolipin IgG & IgM Test - 576 wells

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Histofluor® Rodent LKS Fluorescent Antibody Test System - M7490082891 Catalog Number : 8289

Device Description : Rat LKS Tissue Kit - 800 tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent nDNA Test System - M7490082991 Catalog Number : 8299

Device Description : Custom - nDNA Fluorescent Super Bulk Pack - 4200 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Colorzyme® nDNA Test System - M7490083041 Catalog Number : 8304

Device Description : Custom - nDNA Colorzyme® Bulk Pack - 350 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

RELISA® ENA Multiparameter Antibody Screening Test Sm RNP SSA/Ro SSB/La Scl-70 J - M7490083071 Catalog Number : 8307

Device Description : RELISA® ENA Combination Test System - 96 Wells

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ANCA Test System - M7490083091 Catalog Number : 8309

Device Description : Custom - ANCA BP FA Test System - Ethanol Fixed Substrate - 1400 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

ANCA Test System - M7490083101 Catalog Number : 8310

Device Description : Custom - ANCA BP FA Test System - Formalin Fixed Substrate - 140 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490083111 Catalog Number : 8311

Device Description : Custom - ANA Fluorescent w/cs BP - 7000 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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