Trinity Biotech

Basic Information

• Brand Name: Trinity Biotech
• Primary DI: 05391516744232
• Version / Model: Mobile Phase 1 Reagent - 3.8L
• Catalog Number: 01-03-0040
• Company Name: PRIMUS CORPORATION
• Labeler DUNS: 790074793
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-06
• Public Version: 4
• Public Version Date: 2022-06-10
• Public Version Status: Update
• Public Device Record Key: cf7aa24a-d879-4dda-8104-865eea359317

Device Description

Hemoglobin variants assay, Mobile Phase 1 Reagent - 3.8L

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
GKA	Abnormal Hemoglobin Quantitation	Hematology	864.7415	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55879	Multiple haemoglobin subtype IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative determination of multiple subtypes of haemoglobin in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05391516744232	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K955283	000

Device Sizes

Type	Value	Unit	Text
Total Volume	3.8	Liter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 28 Degrees Celsius