MARDX DIAGNOSTICS, INC.

Address:2823 Girts Rd,Jamestown,NY,14701,US

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Filters

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

Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (LHL) (6) Reagent, Borrelia Serological Reagent (LSR) (3) Anti-Human Globulin, Fta-Abs Test (GMS) (1)

Premarket Exempt

No Yes

Clear

Trinity Biotech - 05391516743976 Catalog Number : 30-7205

Device Description : Legionella DFA Test System, Legionella species b-j, 50 Tests

Device Class : 2

Duns Number: 154281349

Premarket Exempt : Yes

Product Code : LHL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743983 Catalog Number : 30-7305

Device Description : Legionella DFA Test System, (Legionella species, b-p), 50 Tests

Device Class : 2

Duns Number: 154281349

Premarket Exempt : Yes

Product Code : LHL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516743990 Catalog Number : 30-7805

Device Description : LEGIONELLA DFA TEST SYSTEM, (L. pneumophila, Serogroups 1-14), 50 Tests

Device Class : 2

Duns Number: 154281349

Premarket Exempt : Yes

Product Code : LHL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516745673 Catalog Number : 31-8100

Device Description : FTA-ABS Test System (Treponema pallidum Antibody Test System, 100 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : Yes

Product Code : GMS

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746151 Catalog Number : 30-7120

Device Description : Legionella IFA Test System, (L. pneumophila, serogroups 1-6), 120 Tests

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LHL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746168 Catalog Number : 30-7180

Device Description : Legionella IFA Test System, (L. pneumophila, serogroups 1-6), 180 Tests

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LHL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746175 Catalog Number : 30-7360

Device Description : Legionella IFA Test System, (L. pneumophila, serogroups 1-6), 360 Tests

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LHL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746182 Catalog Number : 32-5100G

Device Description : Lyme Disease IgG IFA Test System (100 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746199 Catalog Number : 32-5100M

Device Description : Lyme Disease IgM IFA Test System (100 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746205 Catalog Number : 40-2075G

Device Description : B. burgdorferi (IgG) Marblot Strip Test System (20 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

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