Trinity Biotech 40-2021L

GUDID 05391516747615

B. burgdorferi WB Negative Control, 120µL

MARDX DIAGNOSTICS, INC.

Borrelia burgdorferi antigen IVD, control

• Primary Device ID: 05391516747615
• NIH Device Record Key: 54452795-b08c-461f-ad9f-7cf1434d756b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity Biotech
• Version Model Number: 40-2021L
• Catalog Number: 40-2021L
• Company DUNS: 154281349
• Company Name: MARDX DIAGNOSTICS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• 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	05391516747615 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K950829

FDA Product Code

• LSR: Reagent, Borrelia Serological Reagent

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-18

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