MARDX DIAGNOSTICS, INC.

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

Want to know more about this Organization? Request more information now!

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) (8) Helicobacter Pylori (LYR) (3) Antisera, Fluorescent Antibody For Fta-Abs Test (GMX) (1) Test, Sorbent, Fta-Abs (GMW) (1)

Premarket Exempt

No Yes

Clear

Trinity Biotech - 05391516747660 Catalog Number : 40-2525G

Device Description : Alkaline Phosphatase Conjugate, Anti-Human IgG, 11mL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747677 Catalog Number : 40-2022L

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

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747684 Catalog Number : 40-2029L

Device Description : B. burgdorferi WB Weakly Reactive IgM Control,120µL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747691 Catalog Number : 40-2525M

Device Description : Alkaline Phosphatase Conjugate, Anti-Human IgM, 11 mL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747707 Catalog Number : 44-5017

Device Description : Alkaline Phosphatase Developing Solution, 110mL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747714 Catalog Number : 40-1006

Device Description : EIA Color Developer, 13.0 mL

Device Class : 1

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR, LYR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747721 Catalog Number : 40-1013

Device Description : 10x Wash Solution, 100 mL

Device Class : 1

Duns Number: 154281349

Premarket Exempt : No

Product Code : LSR, LYR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747738 Catalog Number : 41-9002

Device Description : Marsorb G, 10.0 mL

Device Class : 1

Duns Number: 154281349

Premarket Exempt : No

Product Code : LYR, LSR

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747745 Catalog Number : 31-8203

Device Description : FTA-ABS Sorbent, 5.0 mL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : Yes

Product Code : GMW

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516747752 Catalog Number : 31-1503

Device Description : FTA-ABS Conjugate (rodent), 3.0 mL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : Yes

Product Code : GMX

Prescription Use : No

Device Count : 1

Previous 1 … 4 5 6 … 12 Next