Trinity Biotech 01-03-0019

GUDID 05391516748193

Hemoglobin variants assay, Genesys Diluent Reagent - 3.8L

PRIMUS CORPORATION

Multiple haemolobin subtype IVD, reagent
Primary Device ID05391516748193
NIH Device Record Keyc98b888e-3816-49e4-8992-e6277a22c617
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model NumberGenesys Diluent Reagent - 3.8L
Catalog Number01-03-0019
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
Phone800-325-3424
Emailcustomerservice@trinityusa.com
Phone800-325-3424
Emailcustomerservice@trinityusa.com
Phone800-325-3424
Emailcustomerservice@trinityusa.com
Phone800-325-3424
Emailcustomerservice@trinityusa.com
Phone800-325-3424
Emailcustomerservice@trinityusa.com
Phone800-325-3424
Emailcustomerservice@trinityusa.com

Device Dimensions

Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter
Total Volume3.8 Liter

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 28 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516748193 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GKAAbnormal Hemoglobin Quantitation

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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