Procleix Parasite Transport Medium

GUDID 00859882007757

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.

Blood cell lysis reagent IVD
Primary Device ID00859882007757
NIH Device Record Keya328df11-2c11-4cb3-a705-9a064f4ba0e3
Commercial Distribution StatusIn Commercial Distribution
Brand NameProcleix Parasite Transport Medium
Version Model NumberLysis Buffer
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
GS100859882007757 [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

Devices Manufactured by GRIFOLS DIAGNOSTIC SOLUTIONS INC.

00850032683517 - Procleix WNV Assay2025-08-21 The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in hum
00850032683524 - Procleix WNV Assay2025-08-21 The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in hum
00850032683531 - Procleix WNV Assay2025-08-21 The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in hum
00850032683548 - Procleix WNV Assay2025-08-21 The Procleix WNV Assay is a qualitative in vitro nucleic acid assay system for the detection of West Nile Virus (WNV) RNA in hum
00859882007948 - Procleix Xpress System2023-06-19 The Procleix Xpress System (Software and Instrument) is intended to be used to create pools of human plasma or serum for blood s
00850032683005 - Procleix HIV-1/HCV/HBV Quality Control2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control
00850032683012 - Procleix HIV-1/HCV/HBV Quality Control2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control
00850032683029 - Procleix HIV-1/HCV/HBV Quality Control2023-02-23 Procleix® HIV-1/HCV/HBV Quality Control, a set of quality controls, is intended for use as an external assayed quality control

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