FDA.reportPublic FDA data

Procleix Plasmodium Assay

Primary DI
00850032683296
Brand
Procleix Plasmodium Assay
Company
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Model
1K Kit Box 2
Device description
The Procleix Plasmodium Assay is a qualitative in vitro nucleic acid amplification test for the detection of Plasmodium species in whole blood specimens from human donors.
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032683296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032683296008500326832968500326832960850032683296

GMDN Terms#

Term, Definition table
TermDefinition
Multiple Plasmodium species 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 nucleic acid from one or multiple species of Plasmodium (malaria parasites) in a clinical specimen, using a nucleic acid technique (NAT).

Regulatory Flags#

DUNS number
056570085
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850032683289Procleix Plasmodium Assay1K Kit Box 12026-07-13
00850032683302Procleix Plasmodium Assay1K Kit Box 32026-07-13
00850032683319Procleix Plasmodium AssayPlasmodium 1k Calibrator Kit2026-07-13
00850032683326Procleix Plasmodium Assay5K Kit Box 12026-07-13
00850032683333Procleix Plasmodium Assay5K Kit Box 22026-07-13
00850032683340Procleix Plasmodium Assay5K Kit Box 32026-07-13
00850032683357Procleix Plasmodium AssayPlasmodium 5k Calibrator Kit2026-07-13
00850032683609Procleix Panther SystemProcleix Panther System3031602026-07-13
00850032683753Procleix Panther SystemProcleix Panther System (ART, Continuous Fluid andPRD-061222026-07-13
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