Trinity Biotech 44-2020GV

GUDID 05391516748735

EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to Borrelia afzelii “PKO”, Borrelia garinii, and Borrel

MARDX DIAGNOSTICS, INC.

Multiple Borrelia species immunoglobulin A (IgA)/IgG/IgM antibody IVD, kit, fluorescent immunoassay
Primary Device ID05391516748735
NIH Device Record Key4be4c050-bd85-4149-b863-142dfaac5971
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model Number44-2020GV
Catalog Number44-2020GV
Company DUNS154281349
Company NameMARDX DIAGNOSTICS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone800-325-3424
Emailinfo@trinitybiotech.com
Phone800-325-3424
Emailinfo@trinitybiotech.com
Phone800-325-3424
Emailinfo@trinitybiotech.com
Phone800-325-3424
Emailinfo@trinitybiotech.com
Phone800-325-3424
Emailinfo@trinitybiotech.com
Phone800-325-3424
Emailinfo@trinitybiotech.com
Phone800-325-3424
Emailinfo@trinitybiotech.com
Phone800-325-3424
Emailinfo@trinitybiotech.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516748735 [Primary]

FDA Product Code

LSRReagent, Borrelia Serological Reagent

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-18

On-Brand Devices [Trinity Biotech]

05391516749169HEp-2 WB IgG Positive Control, 250 µL
05391516749152Sample Diluent/Wash Powder , 5g
05391516749145Alkaline Phosphatase Conjugate, Anti-Human IgG (Goat), 4.5ml
05391516749138T. pallidum WB IgG Positive Control, 250µl
05391516749121T. pallidum WB Negative Control, 250µl
05391516749114T. pallidum Marblot Strip, 20 each pack
05391516749107L. pneumophila, 1-14, DFA Test Conjugate, (Primate), 1.5 ml
05391516749091L. pneumophila Slides, Serogroups 1-6 Column, pack of 10
05391516749084Legionella species, b-j, Test Conjugate, (Primate), 1.5 mL
05391516749077DFA 2 well Slide, 25 each pack
05391516749015Legionella species, b-j, control slides, pack of 10
05391516748926Leishmania species Positive Control, 250 µL
05391516748919Leishmania species, 6 Well Slide, 8 each pack
05391516748902Lyme Negative Control, 250 uL
05391516748896Primate Adsorbed FITC Bulk Conjugate with Evan’s Blue, 4.0 mL
05391516748889Trypanosoma cruzi 12 well slide, 8 each pack
05391516748872FITC Parasite IgG Conjugate (Rodent), 4.0 mL
05391516748865Trypanosoma cruzi 6 Well Slide, 8 each pack
05391516748858Clostridium difficile Antitoxin, 3 mL
05391516748841Toxi-Titer Diluent, 50 mL
05391516748834Uni-Gold™ H. pylori Antigen Control, 1 Positive and 1 Negative
05391516748827Uni-Gold™ H. pylori Antigen, 20 Tests
05391516748810Uni-Gold™ S. pneumoniae, 20 Tests
05391516748803Uni-Gold™ C. difficile GDH Controls, 1 Positive and 1 Negative
05391516748797Uni-Gold™ C. difficile GDH, 20 Tests
05391516748780Uni-Gold™ C. difficile Toxin A/B Controls, 1 Positive and 1 Negative
05391516748773Uni-Gold™ C. difficile Toxin A/B, 20 Tests
05391516748766Uni-Gold™ Syphilis Treponemal Control, Syphilis Treponemal Positive and Negative Control, 1 Po
05391516748759Uni-Gold™ Syphilis Treponemal, 20 Tests
05391516748742EU – Lyme IgM Western Blot, Western Blot Test System for the Detection of IgM Antibodies to Bo
05391516748735EU Lyme + VlsE IgG Western Blot, Western Blot Test System for the Detection of IgG Antibodies to
05391516748728Liver (IgG) Marblot Strip Test System, Western Blot System for the Detection of IgG Antibody to
05391516748711T. Pallidum IgM Marblot Strip Test System, Western Blot System for the detection of IgM antibod
05391516748704T. Pallidum IgG Marblot Strip Test System, Western Blot System for the detection of IgG antibod
05391516748698Leismaniasis IFA Test System, 48 Tests
05391516748681Trypanosomiasis IFA Test System, 48 Tests
05391516748049Monkey Kidney 8 Well Slides, 12 each pack
05391516748032Monkey Skeletal 4 Well Slides, 12 each pack
05391516748025Anti Skeletal Antibody IFA Test System, 48 Tests
05391516748018GBM Positive Control, 0.5 mL
05391516748001Glomerular Basement Membrane IFA Test System, 48 Tests
05391516747998Toxi-Titer Plate, 48 Wells
05391516747981Legionella Negative DFA Control Conjugate, 1.5 mL
05391516747974B. burgdorferi (IgM) Marblot Strip Test System, 400 Tests
05391516747967B. burgdorferi (IgG) Marblot Strip Test System (400 Tests)
05391516747950Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer
05391516747943FITC Mounting Medium (pH 7.5), 3.0 mL
05391516747936Clostridium difficile Toxin Control, 1.0 mL
05391516747929Coverslips, 70x22 mm, 12 each
05391516747912FITC Mounting Medium (pH 7.5), 3.0 mL
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