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

Antigen, Treponema Pallidum For Fta-Abs Test (JWL) (3) Extractable Antinuclear Antibody, Antigen And Control (LLL) (1)

Premarket Exempt

No Yes

Clear

Trinity Biotech - 05391516749138 Catalog Number : 40-5023

Device Description : T. pallidum WB IgG Positive Control, 250µl

Device Class : 2

Duns Number: 154281349

Premarket Exempt : Yes

Product Code : JWL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516749145 Catalog Number : 40-2024G

Device Description : Alkaline Phosphatase Conjugate, Anti-Human IgG (Goat), 4.5ml

Device Class : 2

Duns Number: 154281349

Premarket Exempt : Yes

Product Code : JWL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516749152 Catalog Number : 40-2030

Device Description : Sample Diluent/Wash Powder , 5g

Device Class : 2

Duns Number: 154281349

Premarket Exempt : Yes

Product Code : JWL

Prescription Use : No

Device Count : 1

Trinity Biotech - 05391516749169 Catalog Number : 40-3022L

Device Description : HEp-2 WB IgG Positive Control, 250 µL

Device Class : 2

Duns Number: 154281349

Premarket Exempt : Yes

Product Code : LLL

Prescription Use : No

Device Count : 1

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