Procleix WNV Assay

GUDID 00859882007030

The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in human plasma and serum.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

West Nile virus nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00859882007030
NIH Device Record Key9efb8f4b-0d1d-459d-a472-f13f29a40fa1
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcleix WNV Assay
Version Model NumberKit Box 2
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
GS100859882007030 [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 WNV Assay]

00859882007054The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
00859882007047The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
00859882007030The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
00859882007023The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
00859882007016The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of
00859882007009The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of

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