Procleix Babesia Assay

GUDID 00859882007733

The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the detection of RNA from Babesia species (B. microti, B. duncani, B. divergens, and B. venatorum) in whole blood specimens.

GRIFOLS DIAGNOSTIC SOLUTIONS INC.

Babesia microti nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00859882007733
NIH Device Record Key646fd713-ce1f-471b-8f88-bbc29625fe16
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcleix Babesia Assay
Version Model NumberBox 3
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
GS100859882007733 [Primary]

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-28
Device Publish Date2019-03-20

On-Brand Devices [Procleix Babesia Assay]

00859882007740The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det
00859882007733The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det
00859882007726The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det
00859882007719The Procleix Babesia Assay is a qualitative in vitro nucleic acid amplification test for the det

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