Trinity Biotech R1129

GUDID 05391516743228

Red Cell Lysing Reagent (4 x 25mL)

TRINITY BIOTECH PUBLIC LIMITED COMPANY

Red cell glucose-6-phosphate dehydrogenase (G6PD) IVD, reagent
Primary Device ID05391516743228
NIH Device Record Key83df26f5-d7cd-477c-9ef1-ee2f7a0793ae
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model NumberR1129
Catalog NumberR1129
Company DUNS988298840
Company NameTRINITY BIOTECH PUBLIC LIMITED COMPANY
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+35312769800
EmailClinicalchemistry.techsupport@

Device Dimensions

Device Size Text, specify0

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516743228 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JBLGlucose-6-Phosphate Dehydrogenase (Erythrocytic), Quantitative

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 Date2016-09-23

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05391516743228Red Cell Lysing Reagent (4 x 25mL)
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