Procleix Ultrio Assay

GUDID 00859882007313

The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and/or hepatitis B virus DNA in human plasma and serum.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00859882007313
NIH Device Record Keyc10abc82-ce65-45c5-aaf4-a1723444bf30
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcleix Ultrio Assay
Version Model NumberHBV Discriminatory Probe Reagent Kit
Company DUNS056570085
Company NameGRIFOLS DIAGNOSTIC SOLUTIONS INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100859882007313 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-09-03
Device Publish Date2018-08-03

On-Brand Devices [Procleix Ultrio Assay]

00859882007351The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007344The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007337The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007320The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007313The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007306The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007290The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007283The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007276The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007269The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007252The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007245The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007238The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection
00859882007221The Procleix Ultrio Assay is a qualitative in vitro nucleic acid assay system for the detection

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