Qstat Control Level 2

Primary DI
00850003761398
Brand
Qstat Control Level 2
Company
HEMOSONICS, LLC
Model
QStat Control Level 2 Kit (Box of 4)
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
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
00850003761398PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850003761398008500037613988500037613980850003761398

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 Celsius8 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
1
HCT/P
true
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
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
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
00850003761046Quantra QPlus SystemKT-00122020-09-28
00850003761039Quantra QPlus SystemHS-0022019-04-24