FDA.reportPublic FDA data

Thromboplastin-LI Reagent Kit

Primary DI
M52552480
Brand
Thromboplastin-LI Reagent Kit
Company
HELENA LABORATORIES CORPORATION
Model
5248
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GJSTEST, TIME, PROTHROMBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GJSTest, Time, ProthrombinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K040296000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K040296000PHOSPHOPLASTIN RLR2 Diagnostics, Inc.2004-05-24GJS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52552480PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Prothrombin time (PT) IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of the prothrombin time (PT) of a clinical specimen, with or without standardization to the international normalized ratio (INR).

Contacts#

Phone, Email table
PhoneEmail
+1(800)231-5663helena@helena.com

Regulatory Flags#

DUNS number
079396131
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M52551830AB-Trol 3 Coagulation Control51832016-08-18
M52551850Coagulation S.A.R.P (Specialty Assayed Reference Plasma)51852016-09-07
M52551860NORM-TROL 1 Coagulation Control51862016-09-07
M52551870AB-TROL 2 Coagulation Control51872016-09-07
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)53012016-09-07
M52553020Coagulation S.A.C.-2 (Specialty Assay Control)53022016-09-07
M52536110H-Pette without Blade (1000 pieces)36112017-05-26
M52536120H-Pette with Blade (1000 pieces)36122017-05-26
M52536130H-Pette Remover36132017-03-17
M52536150H-Pette II (No Blade, Metal Canula) (1000 pieces)36152017-05-26
M52594230IFE Free Lambda Light Chain Antiserum94232024-09-27
M5255527370SPIFE Nexus IFE-6 Antisera Kit5527372024-09-27
M5255527440SPIFE Nexus IFE-9/15 Antisera Kit5527442024-09-27
M52594190IFE IgD Antiserum94192024-09-27
M52594200IFE IgE Antiserum94202024-09-27
M52594220IFE Free Kappa Light Chain Antiserum94222024-09-27
M52520050000ProtoFluor Z (110V)20050002017-03-17
M52520050020ProtoFluor Z (110V)20050022017-03-17
M52520060000ProtoFluor Z (220V)20060002017-03-17
M52518360V8 Urine Preparation Buffer18362023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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09360136000086 Xprecia Prime™ Coagulation AnalyzerUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
09360136000093Xprecia Prime™ PT/INR Test StripsUNIVERSAL BIOSENSORS PTY LTDGJS2024-08-27
08436540291134microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
08436540290915microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-08-02
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08436540290908microINR ® Link KitILINE MICROSYSTEMS SLGJS2024-04-01
00630414639871Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639888Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414639963Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00630414640006Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019593Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019609Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768018749Thromborel SSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00842768019586Dade InnovinSiemens Healthcare Diagnostics Products GmbHGJS2024-03-25
00850053916182IDG/SanzayIDG/SANZAY CorporationGJS2024-01-12
00054749004782i-STAT PTplus CartridgeAbbott Point of Care Inc.GJS2024-01-10
00054749004843i-STAT PTplus Control Level 1Abbott Point of Care Inc.GJS2024-01-10
00054749004850i-STAT PTplus Control Level2Abbott Point of Care Inc.GJS2024-01-10
00365702702356CoaguChek VantusRoche Diagnostics GmbHGJS2023-12-01
00850040656022Assure PT Care PT/INR Monitoring System COAGUSENSE INC.GJS2023-04-06
00850040656039Assure PT Care Test Strip KitCOAGUSENSE INC.GJS2023-04-06
00860007370861Coag-senseCOAGUSENSE INC.GJS2021-09-30
00860007370878Coag-senseCOAGUSENSE INC.GJS2021-09-30
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10861900000395Coag-Sense Test Strip Kit, 50 ct.COAGUSENSE INC.GJS2021-09-09
08436540290717microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28
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08436540290700microINR ® CHIPS ILINE MICROSYSTEMS SLGJS2021-05-28