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

Reagent, Borrelia Serological Reagent (LSR) (7) Reagents, Antibody, Legionella, Direct & Indirect Fluorescent (LHL) (4) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1) For Export Only - Antigen, Anti-Cardiac, Indirect Fluorescent Antibody Test System (NUK) (1) Antigen, Treponema Pallidum For Fta-Abs Test (JWL) (1) Immunofluorescent Assay, T. Cruzi (MIV) (1) Reagent, Leishmanii Serological (LOO) (1) For Export Only - Antigen, Anti-Skeletal, Indirect Fluorescent Antibody Test System (NUL) (1) Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) (MVJ) (1)

Premarket Exempt

No Yes

Clear

Trinity Biotech - 05391516747561 Catalog Number : 30-7500

Device Description : L. pneumophila Negative Control, 0.5 ml

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LHL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747578 Catalog Number : 30-7501

Device Description : L. pneumophila Serogroup 1 Positive Control, 0.5 mL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LHL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747585 Catalog Number : 90-1607

Device Description : Phosphate Buffered Saline, 10g

Device Class : 1

Duns Number: 154281349

Premarket Exempt : No

Product Code : MVJ, NUK, LSR, MIV, NUL, LOO, LHL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747592 Catalog Number : 30-7101

Device Description : L. pneumophila Slides, Serogroups 1-6 Mix, 10 each pack

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LHL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747608 Catalog Number : 32-5010

Device Description : B. burgdorferi 10 Well Slides, 10 each pack

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747615 Catalog Number : 40-2021L

Device Description : B. burgdorferi WB Negative Control, 120µL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747622 Catalog Number : 40-2023L

Device Description : B. burgdorferi WB IgG Serum Band Locator, 250µL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747639 Catalog Number : 40-2027L

Device Description : 40-2027L B. burgdorferi WB Weakly Reactive IgG Control, 120µL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747646 Catalog Number : 40-2017

Device Description : Alkaline Phosphatase Developing Solution, 45mL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR, LLL, JWL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747653 Catalog Number : 40-2019C

Device Description : 10x Sample Diluent/Wash Solution, 100 mL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

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