Trinity Biotech 305-10

GUDID 05391516746014

ACE Reagent

TRINITY BIOTECH PUBLIC LIMITED COMPANY

Angiotensin converting enzyme (ACE) IVD, reagent
Primary Device ID05391516746014
NIH Device Record Keyce40838d-e744-41bd-8925-fd9ff2755542
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model Number305-10
Catalog Number305-10
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
GS105391516746014 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KQNRadioassay, Angiotensin Converting Enzyme

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

On-Brand Devices [Trinity Biotech]

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

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