FDA.reportPublic FDA data

Procleix HIV-1/HCV/HBV Quality Control

Primary DI
00850032683005
Brand
Procleix HIV-1/HCV/HBV Quality Control
Company
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Model
HIV-1/HCV/HBV Negative Control
Device description
Procleix® HIV-1/HCV/HBV 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 Hepatitis B Virus (HBV) DNA, Hepatitis C Virus (HCV) RNA, and Human Immunodeficiency Virus Type 1 (HIV-1) RNA with the Procleix Ultrio Elite Assay performed on the Procleix Panther System.
Published
2023-02-15
Public version status
New
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
BK2207360

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
BK2207360

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032683005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032683005008500326830058500326830050850032683005

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
Kit
true
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
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
00850032683043Procleix WNV/Babesia 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