FDA.reportPublic FDA data

Procleix Ultrio Plus Assay

Primary DI
00859882007214
Brand
Procleix Ultrio Plus Assay
Company
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Model
Negative Control Kit
Published
2018-02-06
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859882007214PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859882007214008598820072148598820072140859882007214

GMDN Terms#

Term, Definition table
TermDefinition
HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of human immunodeficiency virus 1 (HIV1) nucleic acid, Hepatitis C virus nucleic acid and/or Hepatitis B virus nucleic acid in a clinical specimen, using a nucleic acid technique (NAT).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
056570085
Device count
1
Kit
true
Lot or batch
true
Manufacturing date on label
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
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
00859882007269Procleix Ultrio Assay5K Kit Box 22018-08-03