FDA.reportPublic FDA data

Quantra QPlus System

Primary DI
00850003761046
Brand
Quantra QPlus System
Company
HEMOSONICS, LLC
Model
KT-0012
Device description
Quantra Cleaning Cartridge
Published
2020-09-28
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

Product Codes#

Code, Name table
CodeName
QFRCoagulation system for the measurement of whole blood viscoelastic properties

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QFRCoagulation System For The Measurement Of Whole Blood Viscoelastic PropertiesHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
DEN180017000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180017000Quantra Hemostasis Analyzer, QPlus CartridgeHemosonics, LLC2019-03-12QFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850003761043PrimaryGS10
00850003761046Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000376104310850003761043
00850003761046008500037610468500037610460850003761046

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, point-of-care, line-poweredA mains electricity (AC-powered) instrument, which may include internal rechargeable batteries, intended to be used exclusively at the point-of-care by medical professionals for the qualitative and/or quantitative in vitro determination of one or multiple coagulation components involved in haemostasis in a clinical specimen [e.g., performs tests such as whole blood prothrombin time (WBPT), whole blood partial thromboplastin time (WBPTT), heparin dose response, activated clotting time (ACT)]. It may include spectrophotometry, turbidimetry, nephelometry, electrometry and/or mechanical means of clot formation or end point detection.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
193921041
Device count
10
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
10850003761067Quantra QPlus SystemKT-00042019-04-24
10850003761180QStat CartridgeQStat Cartridge KIT (Box of 10)2024-02-29
00850003761336Qstat Control Level 1QStat Control Level 1 Kit (Box of 4)2024-02-29
00850003761398Qstat Control Level 2QStat Control Level 2 Kit (Box of 4)2024-02-29
00850003761183QStat CartridgeQStat Cartridge KIT (Box of 10)2024-02-29
10850003761074Quantra QPlus SystemKT-00332019-04-24
10850003761081Quantra QPlus SystemKT-00342019-04-24
00850003761107Quantra QPlus SystemKT-00392021-02-11
00850003761213Quantra QPlus SystemKT-00232021-02-11
00850003761275Quantra QPlus SystemKT-00252021-02-11
10850003761043Quantra QPlus SystemKT-00122020-09-28
00850003761039Quantra QPlus SystemHS-0022019-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850003761107Quantra QPlus SystemHEMOSONICS, LLCQFR2021-02-11
00850003761213Quantra QPlus SystemHEMOSONICS, LLCQFR2021-02-11
00850003761275Quantra QPlus SystemHEMOSONICS, LLCQFR2021-02-11
10850003761043Quantra QPlus SystemHEMOSONICS, LLCQFR2020-09-28
00850003761039Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24
10850003761067Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24
10850003761074Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24
10850003761081Quantra QPlus SystemHEMOSONICS, LLCQFR2019-04-24