Trinity Biotech 450-3

GUDID 05391516741910

Bile Acids Stop Reagent

TRINITY BIOTECH PUBLIC LIMITED COMPANY

Total bile acid IVD, reagent

• Primary Device ID: 05391516741910
• NIH Device Record Key: 86b80ed4-da67-4f6d-96ff-1e6b18f9b669
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Trinity Biotech
• Version Model Number: 450-3
• Catalog Number: 450-3
• Company DUNS: 988298840
• Company Name: TRINITY BIOTECH PUBLIC LIMITED COMPANY
• 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: +35312769800
• Email: Clinicalchemistry.techsupport@

Device Dimensions

• Total Volume: 50 Milliliter

Operating and Storage Conditions

• Storage Environment Temperature: Between 18 Degrees Celsius and 26 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05391516741910 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K872296

FDA Product Code

• KWW: Radioimmunoassay, Cholyglycine, Bile Acids

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: 2016-09-23

On-Brand Devices [Trinity Biotech]

• 05391516749640: Oxalate Sample Diluent
• 05391516749411: G-6-PDH Substrate 5x10
• 05391516746014: ACE Reagent
• 05391516745680: Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (50 Tests)
• 05391516743228: Red Cell Lysing Reagent (4 x 25mL)
• 05391516743204: Oxalate Urine Control - N
• 05391516743198: Oxalate Urine Control - E
• 05391516742290: Lactate Standard (40 mg/dl)
• 05391516742245: Oxalate Kit
• 05391516742238: Oxalate Kit
• 05391516742221: Oxalate Sample Diluent
• 05391516742214: Oxalate Standards 0.50 MMOL/L
• 05391516742207: Sample Purifier Tubes
• 05391516742191: Oxalate Reagent B
• 05391516742184: Oxalate Standards
• 05391516742177: Sample Purifier Tubes
• 05391516742160: Oxalate Reagent A
• 05391516741927: Bile Acids Kit
• 05391516741910: Bile Acids Stop Reagent
• 05391516741903: Bile Acids Reagent B (25 mL)
• 05391516741897: Bile Acids Controls
• 05391516741880: Bile Acids Reagent B (5 mL)
• 05391516741873: Bile Acids Reagent A (50 mL)
• 05391516741866: Bile Acid Calibrator Set (5 x 5 mL)
• 05391516741859: Bile Acid Calibrator 100 umol/l (5 mL)
• 05391516741712: G-6-PDH Deficiency 100X Kit
• 05391516741705: G-6-PDH Deficiency 5 x 20 Kit
• 05391516741699: Mineral Oil
• 05391516741682: Mineral Oil
• 05391516741675: Trizma Buffer Solution
• 05391516741651: G-6-PDH Substrate 10x10
• 05391516741552: Glucose-6-Phosphate Dehyrodgenase (G-6-PDH) (20 Tests)
• 05391516741521: G-6-PDH Deficiency (50 Tests)