FDA.reportPublic FDA data

Quantra QPlus System

Primary DI
00850003761107
Brand
Quantra QPlus System
Company
HEMOSONICS, LLC
Model
KT-0039
Catalog number
KT-0039
Device description
Quantra Desktop Remote Viewer
Published
2021-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

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
K201513000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
DEN180017000Quantra Hemostasis Analyzer, QPlus CartridgeHemosonics, LLC2019-03-12QFR
K201513000Quantra QPlus SystemHemosonics, LLC2020-08-21QFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850003761107PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003761107008500037611078500037611070850003761107

GMDN Terms#

Term, Definition table
TermDefinition
Coagulation analyser IVD, laboratoryAn electrically-powered automated or semi-automated laboratory instrument intended to be used 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 prothrombin time (PT), partial thromboplastin time (PTT)]. Analyser design may incorporate spectrophotometry, turbidimetry, nephelometry, electrometry, electromagnetic and/or mechanical means of clot formation or end point detection.

Contacts#

Phone, Email table
PhoneEmail
+1(800)280-5589support@hemosonics.com

Regulatory Flags#

DUNS number
193921041
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
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
00850003761213Quantra QPlus SystemKT-00232021-02-11
00850003761275Quantra QPlus SystemKT-00252021-02-11
10850003761043Quantra QPlus SystemKT-00122020-09-28
00850003761046Quantra QPlus SystemKT-00122020-09-28
00850003761039Quantra QPlus SystemHS-0022019-04-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850003761213Quantra QPlus SystemHEMOSONICS, LLCQFR2021-02-11
00850003761275Quantra QPlus SystemHEMOSONICS, LLCQFR2021-02-11
10850003761043Quantra QPlus SystemHEMOSONICS, LLCQFR2020-09-28
00850003761046Quantra 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