FDA.reportPublic FDA data

Procleix WNV/Babesia Quality Control

Primary DI
00850032683043
Brand
Procleix WNV/Babesia Quality Control
Company
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Model
WNV/Babesia Negative Control
Device description
Procleix WNV/Babesia Quality Control, a set of quality controls, is intended for use as an external assayed quality control material to monitor the performance of the qualitative detection of RNA from Babesia microti and West Nile Virus (WNV) with the Procleix Babesia Assay and Procleix WNV Assay respectively performed on the Procleix Panther System.
Published
2023-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QTMAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTMAssayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays For Blood Donor Screening.Microbiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
BK2207460

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2207460

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032683043PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032683043008500326830438500326830430850032683043

GMDN Terms#

Term, Definition table
TermDefinition
PCR/NAT negative control IVDA material or solution, known to give a negative result, intended to be used to verify the performance and/or identify contamination, or non-specific amplification in a qualitative and/or quantitative assay performed on a clinical specimen using a nucleic acid technique (NAT) or polymerase chain reaction (PCR).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-452-6877service.americas@grifols.com

Regulatory Flags#

DUNS number
056570085
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859882007061Procleix Ultrio Plus Assay1K Kit Box 12018-02-06
00859882007078Procleix Ultrio Plus Assay1K Kit Box 22018-02-06
00859882007085Procleix Ultrio Plus Assay1K Kit Box 32018-02-06
00859882007092Procleix Ultrio Plus Assay1K Kit Box 42018-02-06
00859882007108Procleix Ultrio Plus Assay5K Kit Box 12018-02-06
00859882007115Procleix Ultrio Plus Assay5K Kit Box 22018-02-06
00859882007122Procleix Ultrio Plus Assay5K Kit Box 32018-02-06
00859882007139Procleix Ultrio Plus Assay5K Kit Box 42018-02-06
00859882007146Procleix Ultrio Plus Assay5K Kit Box 52018-02-06
00859882007153Procleix Ultrio Plus AssayHIV-1 dprobe kit2018-02-06
00859882007160Procleix Ultrio Plus AssayHCV dprobe kit2018-02-06
00859882007177Procleix Ultrio Plus AssayHBV dprobe kit2018-02-06
00859882007184Procleix Ultrio Plus AssayControls Kit2018-02-06
00859882007191Procleix Ultrio Plus AssayCalibrators Kit2018-02-06
00859882007207Procleix Ultrio Plus AssayNegative Calibrator Kit2018-02-06
00859882007214Procleix Ultrio Plus AssayNegative Control Kit2018-02-06
00859882007221Procleix Ultrio Assay1K Kit Box 12018-08-03
00859882007238Procleix Ultrio Assay1K Kit Box 22018-08-03
00859882007245Procleix Ultrio Assay1K Kit Box 32018-08-03
00859882007252Procleix Ultrio Assay5K Kit Box 12018-08-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850032683005Procleix HIV-1/HCV/HBV Quality ControlGRIFOLS DIAGNOSTIC SOLUTIONS INC.QTM2023-02-15
00850032683012Procleix HIV-1/HCV/HBV Quality ControlGRIFOLS DIAGNOSTIC SOLUTIONS INC.QTM2023-02-15
00850032683029Procleix HIV-1/HCV/HBV Quality ControlGRIFOLS DIAGNOSTIC SOLUTIONS INC.QTM2023-02-15
00850032683036Procleix HIV-1/HCV/HBV Quality ControlGRIFOLS DIAGNOSTIC SOLUTIONS INC.QTM2023-02-15
00850032683050Procleix WNV/Babesia Quality ControlGRIFOLS DIAGNOSTIC SOLUTIONS INC.QTM2023-02-15
00850032683067Procleix WNV/Babesia Quality ControlGRIFOLS DIAGNOSTIC SOLUTIONS INC.QTM2023-02-15