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

Reagent, Borrelia Serological Reagent (LSR) (6) Autoantibodies, Anti-Ribonucleic Acid Polymerase (Rnap) Iii Antibody (NYO) (1)

Premarket Exempt

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IMMCO DIAGNOSTICS - 00845714004391 Catalog Number : 1140-240X

Device Description : Anti-neutrophil cytoplasmic Antibody (ANCA) IFA Kit

Device Class :

Duns Number: 079935300

Premarket Exempt : No

Product Code :

Prescription Use : Yes

Device Count : 1

Immco Diagnostics, Inc. - 00845714004704 Catalog Number : 6101G-50

Device Description : Lyme B. burgdorferi (IgG) Marstripe Test

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Immco Diagnostics, Inc. - 00845714004711 Catalog Number : 6101G

Device Description : Lyme B. burgdorferi (IgG) Marstripe Test

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Immco Diagnostics, Inc. - 00845714004728 Catalog Number : 6101G-400

Device Description : Lyme B. burgdorferi (IgG) Marstripe Test

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Immco Diagnostics, Inc. - 00845714004810 Catalog Number : 6101M-50

Device Description : Lyme B. burgdorferi (IgM) Marstripe Test

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Immco Diagnostics, Inc - 00845714004827 Catalog Number : 5170

Device Description : Enhanced Anti-RNA POL lll Antibody ELISA

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : NYO

Prescription Use : Yes

Device Count : 1

Immco Diagnostics, Inc. - 00845714004834 Catalog Number : 6101M

Device Description : Lyme B. burgdorferi (IgM) Marstripe Test

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

Immco Diagnostics, Inc. - 00845714004841 Catalog Number : 6101M-400

Device Description : Lyme B. burgdorferi (IgM) Marstripe Test

Device Class : 2

Duns Number: 079935300

Premarket Exempt : No

Product Code : LSR

Prescription Use : Yes

Device Count : 1

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