Trinity Biotech 30-7104

GUDID 05391516749091

L. pneumophila Slides, Serogroups 1-6 Column, pack of 10

MARDX DIAGNOSTICS, INC.

Legionella pneumophila total antibody IVD, kit, fluorescent immunoassay
Primary Device ID05391516749091
NIH Device Record Keyb42884d8-9d3b-454e-997c-2f97b579f142
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model Number30-7104
Catalog Number30-7104
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 Kitfalse
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

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516749091 [Primary]

FDA Product Code

LHLReagents, Antibody, Legionella, Direct & Indirect Fluorescent

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

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05391516748865Trypanosoma cruzi 6 Well Slide, 8 each pack
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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
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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
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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
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05391516747950Bartels® Cytotoxicity Assay for Clostridium difficile Toxin Product B1029-70, Store Toxi-Titer
05391516747943FITC Mounting Medium (pH 7.5), 3.0 mL
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