Procleix Panther System

Primary DI
00850032683753
Brand
Procleix Panther System
Company
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Model
Procleix Panther System (ART, Continuous Fluid and
Catalog number
PRD-06122
Device description
The Procleix Panther System is an integrated nucleic acid testing system which fully automates all steps necessary to perform Procleix assays from sample processing through amplification, detection, and data reduction. The Procleix assays are qualitative and/or quantitative in vitro nucleic acid amplification tests for the detection of pathogenic viruses in human specimens, as defined in the assay package insert.
Published
2026-07-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850032683753PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850032683753008500326837538500326837530850032683753

GMDN Terms#

Term, Definition table
TermDefinition
Isothermal nucleic acid amplification analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to amplify target deoxyribonucleic acid (DNA) or ribonucleic acid (RNA) in a clinical specimen at a constant (isothermal) temperature, using a series of transcription and reverse transcription reactions, and to detect and/or identify the amplified product using oligonucleotide markers as it is produced (e.g., in real-time).

Regulatory Flags#

DUNS number
056570085
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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
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
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