Trinity Biotech 01-04-0044

GUDID 05391516748315

Hemoglobin variants assay, Premier Resolution A2+F Calibrator Kit

PRIMUS CORPORATION

Multiple haemoglobin subtype IVD, calibrator
Primary Device ID05391516748315
NIH Device Record Keya4931550-31fb-46c4-905d-96c96e415944
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrinity Biotech
Version Model NumberPremier Resolution A2+F Calibrator Kit
Catalog Number01-04-0044
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

Phone800-325-3424
Emailcustomerservice@trinityusa.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS105391516748315 [Primary]

FDA Product Code

JCMControl, Hemoglobin, Abnormal

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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05391516748117Hemoglobin A1c assay, Premier Sample Diluent Reagent - 940mL
05391516748100Hemoglobin A1c assay, Premier Buffer B Reagent - 3.8L
05391516748094Hemoglobin A1c assay, Premier Buffer A Reagent - 3.8L
05391516748087Hemoglobin A1c assay, HbA1c (GHb) Controls Kit, 500uL (Levels I & II) - 1 kit
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05391516744799Hemoglobin A1c assay, Premier Wash Reagent - 940mL
05391516744782Hemoglobin A1c assay, Premier Diluent Reagent - 3.8L
05391516744775Hemoglobin A1c assay, Premier Buffer B Reagent - 940mL
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05391516744317Hemoglobin A1c assay, 2 Diluent Reagent - 940mL
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05391516744287Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 3.8L
05391516744270Hemoglobin A1c assay, Ultra2 Buffer 2A Reagent - 940mL
05391516744263Hemoglobin variants assay, Mobile Phase 2 Reagent - 940mL
05391516744256Hemoglobin variants assay, Mobile Phase 1 Reagent - 940mL
05391516744249Hemoglobin variants assay, Mobile Phase 2 Reagent - 3.8L
05391516744232Hemoglobin variants assay, Mobile Phase 1 Reagent - 3.8L
05391516744218Hemoglobin A1c assay, System Wash Reagent - 940mL
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05391516744171Hemoglobin A1c assay, Ultra2 Buffer B Reagent - 3.8L
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