Trinity Biotech 01-03-0012

GUDID 05391516744171

Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 3.8L

PRIMUS CORPORATION

Glycated haemoglobin (HbA1c) IVD, reagent
Primary Device ID05391516744171
NIH Device Record Key2cb1b4d5-3ce2-4a6f-9967-591797f176e2
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model NumberUltra2 Buffer B Reagent - 3.8L
Catalog Number01-03-0012
Company DUNS790074793
Company NamePRIMUS CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
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

Phone800-325-3424
Emailcustomerservice@trinityusa.com

Device Dimensions

Total Volume3.8 Liter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516744171 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCPAssay, Glycosylated Hemoglobin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-06

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