Trinity Biotech 41-1020G

GUDID 05391516748728

Liver (IgG) Marblot Strip Test System, Western Blot System for the Detection of IgG Antibody to Liver Antigens, 20 Tests

MARDX DIAGNOSTICS, INC.

Protein electrophoresis IVD, kit, electrophoresis

• Primary Device ID: 05391516748728
• NIH Device Record Key: 0475b96d-6b17-4146-959e-62a8166bf0c8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity Biotech
• Version Model Number: 41-1020G
• Catalog Number: 41-1020G
• Company DUNS: 154281349
• Company Name: MARDX DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-325-3424
• Email: info@trinitybiotech.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391516748728 [Primary]

FDA Product Code

• NBS: Autoantibodies,Lkm-1(Liver/Kidney Microsome,Type 1)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

On-Brand Devices [Trinity Biotech]

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