Procleix Ultrio Plus Assay

GUDID 00859882007153

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00859882007153
NIH Device Record Key219987e2-0bf0-4d98-9178-563c55ca0a23
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcleix Ultrio Plus Assay
Version Model NumberHIV-1 dprobe 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100859882007153 [Primary]

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 Date2018-02-06

On-Brand Devices [Procleix Ultrio Plus Assay]

00859882007214Negative Control Kit
00859882007207Negative Calibrator Kit
00859882007191Calibrators Kit
00859882007184Controls Kit
00859882007177HBV dprobe kit
00859882007160HCV dprobe kit
00859882007153HIV-1 dprobe kit
008598820071465K Kit Box 5
008598820071395K Kit Box 4
008598820071225K Kit Box 3
008598820071155K Kit Box 2
008598820071085K Kit Box 1
008598820070921K Kit Box 4
008598820070851K Kit Box 3
008598820070781K Kit Box 2
008598820070611K Kit Box 1

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