Trinity Biotech 03-06-0011

GUDID 05391516748216

Hemoglobin A1c assay, Tri-stat Liquid Controls Kit

PRIMUS CORPORATION

Glycated haemoglobin (HbA1c) IVD, control
Primary Device ID05391516748216
NIH Device Record Keyd014d69e-2291-4754-89c9-3f8fc041a7fd
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model NumberTri-stat Liquid Controls Kit
Catalog Number03-06-0011
Company DUNS790074793
Company NamePRIMUS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Producttrue
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone810-325-3424
Emailcustomerservice@trinityusa.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516748216 [Primary]

FDA Product Code

JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-06

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