QStat Cartridge

Primary DI
00850003761183
Brand
QStat Cartridge
Company
HEMOSONICS, LLC
Model
QStat Cartridge KIT (Box of 10)
Device description
For Use with the QUANTRA® Hemostasis Analyzer
Published
2024-02-29
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

Contact Domains#

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K213917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K213917000QStat CartridgeHemosonics, LLC2022-11-29QFR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850003761180PrimaryGS10
00850003761183Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000376118010850003761180
00850003761183008500037611838500037611830850003761183

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius28 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
193921041
Device count
10
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
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
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
00850003761046Quantra QPlus SystemKT-00122020-09-28
00850003761039Quantra QPlus SystemHS-0022019-04-24