Trinity Biotech

GUDID 05391516746533

Substrate Solution (TMB)

CLARK LABORATORIES, INC.

Chromogenic substrate reagent IVD

• Primary Device ID: 05391516746533
• NIH Device Record Key: 0ee0f840-b3e2-49c1-85a9-c0ee728cfbe7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity Biotech
• Version Model Number: 525700
• Company DUNS: 623214079
• Company Name: CLARK LABORATORIES, 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: false
• 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: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com
• Phone: 1-800-325-3424
• Email: customerservice@trinityusa.com

Device Dimensions

• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter
• Total Volume: 15 Milliliter

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391516746533 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K873088

FDA Product Code

• LFX: Enzyme Linked Immunoabsorbent Assay, Rubella

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-01-06
• Device Publish Date: 2019-12-27

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• 05391516747189: Captia™ Borrelia burgdorferi IgG/IgM
• 05391516747172: Captia™ ENA Combined Screen
• 05391516747165: Captia™ Histone
• 05391516747158: Captia™ Rheumatoid Factor IgM
• 05391516747141: Captia™ ds/DNA
• 05391516747110: Captia™ Mumps IgG
• 05391516747066: Captia™ Varicella-Zoster Virus (VZV) IgG
• 05391516747059: Captia™ Herpes Simplex Virus 2 (HSV 2) IgM
• 05391516747042: Captia™ Herpes Simplex Virus 2 (HSV 2) IgG
• 05391516747035: Captia™ Herpes Simplex Virus 1 (HSV 1) IgM
• 05391516747028: Captia™ Herpes Simplex Virus 1 (HSV1) IgG
• 05391516747011: Captia™ Rubella IgM
• 05391516747004: Captia™ Rubella IgG
• 05391516746991: Captia™ Cytomegalovirus (CMV) IgM
• 05391516746984: Captia™ Cytomegalovirus (CMV) IgG
• 05391516746977: Captia™ Toxoplasma gondii IgM
• 05391516746960: Captia™ Toxoplasma gondii IgG
• 05391516746939: Captia™ HSV 2 Type Specific IgG
• 05391516746922: Captia™ HSV 1 Type Specific IgG
• 05391516746496: Captia™ Herpes Group IgG
• 05391516746489: Captia™ Herpes Simplex Virus (HSV) Combined IgM
• 05391516745147: Captia™ Malaria EIA
• 05391516745130: CAPTIA™ Malaria EIA
• 05391516745123: CAPTIA™ Malaria EIA
• 05391516745109: CAPTIA™ Syphilis TA EIA
• 05391516745093: CAPTIA™ Syphilis TA EIA
• 05391516745048: CAPTIA™ NMT Syphilis IgM
• 05391516745031: CAPTIA™ CMV TA EIA
• 05391516745024: CAPTIA™ CMV TA EIA
• 05391516744836: CAPTIA™ Syphilis (T. Pallidum)-G
• 05391516744829: CAPTIA™Syphilis (T. Pallidum)-G
• 05391516744065: Bartels ELISA Legionella Urinary Antigen
• 05391516743952: Captia™ Chlamydia IgG
• 05391516743938: Macra® Lp(a)
• 05391516743914: Captia™ANA Screen
• 05391516743891: Captia™ PR-3
• 05391516743877: Captia™ MPO
• 05391516743860: Captia™ ENA Combined Screen
• 05391516743839: Captia™ Mitochondria
• 05391516743822: Captia™ ENA Profile
• 05391516743808: Captia™ Thyroglobulin
• 05391516743792: Captia™ Jo-1
• 05391516743785: Captia™ Scl-70
• 05391516743778: Captia™ Sm/RNP
• 05391516743761: Captia™ Smith (Sm)
• 05391516743754: Captia™ SSB (La)