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) (4) Antibodies, Gliadin (MST) (2) Antinuclear Antibody, Antigen, Control (LKJ) (2) Test System, Antineutrophil Cytoplasmic Antibodies (Anca) (MOB) (2)

Premarket Exempt

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IMMCO DIAGNOSTICS - 00845714000003 Catalog Number : 1102

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 - 00845714000010 Catalog Number : 1103

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 - 00845714000027 Catalog Number : 1114

Device Description : Anti-Endomysial Antibody (EMA) IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : DBL

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000034 Catalog Number : 1114-96

Device Description : Anti-Endomysial Antibody (EMA) IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : DBL

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000041 Catalog Number : 1117A

Device Description : Anti-gliadin IgA antibody ELISA

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : MST

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000058 Catalog Number : 1117G

Device Description : Anti-gliadin IgG antibody ELISA

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : MST

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000089 Catalog Number : 1136

Device Description : COMVI III Mouse Liver/Kidney/Stomach IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : DBL

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000096 Catalog Number : 1136-96

Device Description : COMVI III Mouse Liver/Kidney/Stomach IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : DBL

Prescription Use : Yes

Device Count : 1

IMMCO DIAGNOSTICS - 00845714000102 Catalog Number : 1140

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 - 00845714000119 Catalog Number : 1141

Device Description : Anti-neutrophil Cytoplasmic Antibody (pANCA) IFA Kit

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : MOB

Prescription Use : Yes

Device Count : 1

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