FDA.reportPublic FDA data

Procleix Parasite Transport Medium

Primary DI
00859882007757
Brand
Procleix Parasite Transport Medium
Company
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Model
Lysis Buffer
Device description
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.
Published
2019-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859882007757PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859882007757008598820077578598820077570859882007757

GMDN Terms#

Term, Definition table
TermDefinition
Blood cell lysis reagent IVDA substance or reactant intended to be used alone or in combination with other IVDs to disrupt the cell membrane of blood cells [red blood cells (RBCs), white blood cells (WBCs) and/or platelets] to release cytoplasmic contents in preparation for further analysis.

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
00850032683289Procleix Plasmodium Assay1K Kit Box 12026-07-13
00850032683296Procleix Plasmodium Assay1K Kit Box 22026-07-13
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