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) (10)

Premarket Exempt

No Yes

Clear

Trinity Biotech - 05391516746212 Catalog Number : 40-2075M

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

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746229 Catalog Number : 40-5065G

Device Description : B. burgdorferi (IgG) Marblot Strip Test System (50 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746236 Catalog Number : 40-5065G/B

Device Description : B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746243 Catalog Number : 40-5065M

Device Description : B. burgdorferi (IgM) Marblot Strip Test System (50 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746250 Catalog Number : 40-5065M/B

Device Description : B. burgdorferi (IgM) Marblot Strip Test System (400 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746267 Catalog Number : 40-8696G

Device Description : B. burgdorferi EIA (IgG) Test System (96 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746274 Catalog Number : 40-8696M

Device Description : B. burgdorferi EIA (IgM) Test System (96 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746281 Catalog Number : 40-8696M/J

Device Description : B. burgdorferi EIA (IgM) Test System (480 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746298 Catalog Number : 40-8696P

Device Description : B. burgdorferi EIA (IgG, IgM) Test System (96 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516746304 Catalog Number : 40-8696P/J

Device Description : B. burgdorferi EIA (IgG, IgM) Test System (480 Tests)

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

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