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

Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use (PIV) (2)

Premarket Exempt

Clear

ANCA Test System - M7490083141 Catalog Number : 8314

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

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

RELISA® Cardiolipin IgG & IgM Antibody Test - M7490083161 Catalog Number : 8316

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

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490083171 Catalog Number : 8317

Device Description : Custom - ANA Fluorescent w/cs Bulk Pack - 1800 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

HEp-2000® Fluorescent ANA-Ro Test System - M7490084001 Catalog Number : 8400

Device Description : Custom: ANA FA Super Bulk Pack - 5400 Tests

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Image Navigator® - M74900IN1101 Catalog Number : IN110

Device Description : Automated microscope system for immunofluorescent determination of autoantibodies.

Device Class : 2

Duns Number: 038271904

Premarket Exempt : No

Product Code : PIV

Prescription Use : Yes

Device Count : 1

Image Navigator® - M74900IN2201 Catalog Number : IN220

Device Description : Automated microscope system for immunofluorescent determination of autoantibodies.

Device Class : 2

Duns Number: 038271904

Premarket Exempt : No

Product Code : PIV

Prescription Use : Yes

Device Count : 1

Fluorescent ANA Test System - M74900M1211 Catalog Number : M12 (1)

Device Description : OEM ANA HEp-2 - 1 x 12 well slide

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

IMMUNO CONCEPTS RELISA® Test Systems - M7490103141 Catalog Number : 1031 (4)

Device Description : RELISA® Wash Buffer Concentrate - 4 x 10ml

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

IMMUNO CONCEPTS Substrate Slide Test Systems - M7490104211 Catalog Number : 1042 (1)

Device Description : Coverslips 24 x 64mm - 1 oz

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

Fluorescent ANA Test System - M7490110541 Catalog Number : 1105 (4)

Device Description : Universal Counterstain (0.5% Evan's Blue) - 4 x 5 ml

Device Class :

Duns Number: 038271904

Premarket Exempt : No

Product Code :

Prescription Use : No

Device Count : 1

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