MARDX DIAGNOSTICS, INC.

Matched from indexed company URL: MARDX, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
2245544	1000124273	MARDX DIAGNOSTICS, INC.	1	N	2020-04-25	5919 FARNSWORTH CT. CARLSBAD CA US 92008

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
05391516747585	Trinity Biotech - Phosphate Buffered Saline, 10g	800-325-3424	info@trinitybiotech.com
05391516747851	Trinity Biotech - Alkaline Phosphatase Conjugate, Anti-Human IgG (Goat), 4.5 mL	800-325-3424	info@trinitybiotech.com
05391516747943	Trinity Biotech - FITC Mounting Medium (pH 7.5), 3.0 mL	800-325-3424	info@trinitybiotech.com

trinitybiotech.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
16361	1143452186	K964787	MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM	LLL	1997-04-08
16361	1239954114	K951709	MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM	LSR	1996-06-07
16361	1997207700	K950829	MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM	LSR	1996-06-05
16361	1405923404	K894609	MARDX LYME DISEASE IFA (IGM) TEST SYSTEM	LSR	1989-09-19
16361	1298382108	K890053	MARDX LYME DISEASE IGG IFA TEST SYSTEM	LSR	1989-04-18
16361	1271600515	K833447	CYTOTOXICITY ASSAY FOR CLOSTRIDIUM-	MCB	1984-05-21
16361	2052206354	K832896	LEGIONELLA INDIRECT FLUORESCENT ANTIBOD	LHL	1983-10-14
16361	1191307620	K121565	UNI-GOLD CRYPTOSPORIDIUM	MHJ	2013-02-08
16361	1339867297	K120001	UNIGOLD GIARDIA	MHI	2013-03-01
16361	1005485350
16361	1011032250
16361	1033806755
16361	1072305152
16361	1128538537
16361	1130060928
16361	1216175822
16361	1266880882
16361	1380118613
16361	1401954966
16361	1483564866
16361	1554490629
16361	1596354342
16361	1625224924
16361	1854231048
16361	1855503091
16361	1908358526
16361	1936760945
16361	1936919353
16361	2071310439

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
LSR	4	1996-06-07
MHI	1	2013-03-01
MHJ	1	2013-02-08
LLL	1	1997-04-08
MCB	1	1984-05-21
LHL	1	1983-10-14

PMN#

MARDX ENA IGG IMMUNOSTRIPE TEST SYSTEM / MARDX ENA IGG MARSTRIPE TEST SYSTEM

1997-04-08

MARDX DIAGNOSTICS, INC.

MARDX LYME DISEASE (IGM) MARBLOT STRIP TEST SYSTEM

1996-06-07

MARDX DIAGNOSTICS, INC.

MARDX LYME DISEASE (IGG) MARBLOT STRIP TEST SYSTEM

1996-06-05

MARDX DIAGNOSTICS, INC.

DSDNA IMMUNOGLOBULIN EIA TEST SYSTEM

1996-03-20

MARDX DIAGNOSTICS, INC.

MARDX LYME DISEASE IFA (IGM) TEST SYSTEM

1989-09-19

MARDX, INC.

MARDX LYME DISEASE EIA (IGM) TEST SYSTEM

1989-08-21

MARDX DIAGNOSTICS, INC.

MARDX LYME DISEASE EIA (IGG) TEST SYSTEM

1989-08-21

MARDX DIAGNOSTICS, INC.

MARDX LLYME DISEASE EIA (IGG & IGM) TEST SYSTEM

1989-08-15

MARDX DIAGNOSTICS, INC.

MARDX LYME DISEASE IGG IFA TEST SYSTEM

1989-04-18

MARDX DIAGNOSTICS, INC.

GUDID#

Trinity Biotech - Leishmania species Positive Control, 250 µL

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Leishmania species, 6 Well Slide, 8 each pack

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Leismaniasis IFA Test System, 48 Tests

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - FITC Mounting Medium (pH 7.5), 3.0 mL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - Phosphate Buffered Saline, 10g

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Alkaline Phosphatase Conjugate, Anti-Human IgG (Goat), 4.5 mL

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM Antibodies to Borrelia afzelii “PKO” and Borrelia garinii, 40 Tests

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to Borrelia afzelii “PKO”, Borrelia garinii, and Borrelia burgdorferi VlsE, 40 Tests

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Marsorb G, 10.0 mL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - 10x Wash Solution, 100 mL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - Lyme Disease IgM IFA Test System (100 Tests)

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Lyme Disease IgG IFA Test System (100 Tests)

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Clostridium difficile Antitoxin, 3 mL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - Toxi-Titer Diluent, 50 mL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - Toxi-Titer Plate, 48 Wells

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - B. burgdorferi (IgM) Marblot Strip Test System, 400 Tests

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer Plate @ 35-37 °C, Store Reagents @ 2-8 °C, 48 Tests

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Alkaline Phosphatase Developing Solution, 110mL

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Alkaline Phosphatase Conjugate, Anti-Human IgM, 11 mL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - B. burgdorferi WB Weakly Reactive IgM Control,120µL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - B. burgdorferi WB IgM Serum Band Locator, 250µL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - Alkaline Phosphatase Conjugate, Anti-Human IgG, 11mL

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - 10x Sample Diluent/Wash Solution, 100 mL

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - 40-2027L B. burgdorferi WB Weakly Reactive IgG Control, 120µL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - B. burgdorferi WB IgG Serum Band Locator, 250µL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - B. burgdorferi WB Negative Control, 120µL

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - B. burgdorferi 10 Well Slides, 10 each pack

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - L. pneumophila Slides, Serogroups 1-6 Mix, 10 each pack

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - L. pneumophila Serogroup 1 Positive Control, 0.5 mL

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - L. pneumophila Negative Control, 0.5 ml

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - FITC Labeled Anti-Human (Primate) IgG Conjugate, 1.5 mL

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - Lyme IgM Positive Control, 250 uL

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Lyme IgG Positive Control, 250 uL

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - L. pneumophila Slides, Serogroups 1-6, 10 each pack

MARDX DIAGNOSTICS, INC.

2016-09-19

Trinity Biotech - Uni-Gold™ Cryptosporidium Control, Cryptosporidium Positive and Negative Control, 1 Positive and 1 Negative

MARDX DIAGNOSTICS, INC.

2016-09-18

TrinityBiotech - Uni-Gold™ Cryptosporidium, 20 Tests

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Uni-Gold™ Giardia Control, Giardia Positive and Negative Control, 1 Positive and 1 Negative

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - Uni-Gold™ Giardia, 20 Tests

MARDX DIAGNOSTICS, INC.

2016-09-18

Trinity Biotech - B. burgdorferi EIA (IgG, IgM) Test System (480 Tests)

MARDX DIAGNOSTICS, INC.

2016-09-18

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