IMMCO DIAGNOSTICS, INC.

Address:10 Earhart Drive,Williamsville,NY,14221,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

Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control (DBL) (3) Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls (LJM) (2) Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control (DHN) (2) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (2) Antinuclear Antibody, Antigen, Control (LKJ) (1)

Premarket Exempt

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IMMCO DIAGNOSTICS - 00845714000126 Catalog Number : 1142

Device Description : COMVI Anti-Neutrophil Cytoplasmic Antibody (c+pANCA) IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : MOB

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000218 Catalog Number : 1175

Device Description : Anti-nuclear Antigen (ANA) Screen ELISA

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000249 Catalog Number : 1102-60

Device Description : Hep-2 Cells -Anti-Nuclear Antibody IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : LKJ

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000263 Catalog Number : 1106

Device Description : Anti-nDNA Antibody IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : DHN

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000270 Catalog Number : 1106-2

Device Description : Anti-nDNA Antibody IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : DHN

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000287 Catalog Number : 1107

Device Description : COMVI Mouse Kidney/Stomach IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : DBL

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000317 Catalog Number : 1116

Device Description : Anti-Neutrophil Cytoplasmic Antibody (ANCA) IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : MOB

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000362 Catalog Number : 1119

Device Description : Anti-Histone Antibody (AHA) ELISA

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : LJM

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000393 Catalog Number : 1125

Device Description : COMVI-I Hep-2/Mouse Kidney IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : DBL

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000430 Catalog Number : 1134

Device Description : COMVI-II Hep-2 Mouse Kidney/Stomach IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : DBL

Prescription Use : Yes

Device Count : 1

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