FDA.reportPublic FDA data

Helena Fibrinogen Calibrator

Primary DI
M52553790
Brand
Helena Fibrinogen Calibrator
Company
HELENA LABORATORIES CORPORATION
Model
5379
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
KQJSYSTEM, FIBRINOGEN DETERMINATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KQJSystem, Fibrinogen DeterminationHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K841020000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K841020000FIBRINOGEN ASSAY KITHelena Laboratories1984-05-02KQJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52553790PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Fibrinogen assay (factor I) IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the quantitative measurement of fibrinogen (factor I) in a clinical specimen.

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
Primary DIBrandCompanyProduct codePublished
00630414639734Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414639741Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414639901Dade CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640150Dade Data-Fi Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640266Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640273Dade Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640372Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768018541Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768018503Multifibren USiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019845Dade CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019524Dade Data-Fi Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019517Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019494Dade Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00842768019500Dade Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
00630414640532Kaolin SuspensionSiemens Healthcare Diagnostics Products GmbHKQJ2024-03-25
G0561009890Calcium ChlorideBio/Data CorporationKQJ2023-08-30
00859394006040FibrotekR 2 DIAGNOSTICS, INC.KQJ2016-11-15
05051700010726Human Fibrinogen BINDARID™ Radial Immunodiffusion KitTHE BINDING SITE GROUP LIMITEDKQJ2016-09-24
00842768003936Dade® Data-Fi® Abnormal Fibrinogen ControlSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003943Dade® Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003950Dade® Thrombin ReagentSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768003981Dade® Owren's Veronal BufferSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768007170Kaolin SuspensionSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768017865Multifibren® USiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768017872Multifibren® USiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
00842768039416Dade® CA System BufferSiemens Healthcare Diagnostics Products GmbHKQJ2016-09-24
08426950451976HemosIL Low Fibrinogen ControlINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
08426950087618HemosIL Fibrinogen-C XLINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
08426950478676HemosIL Fibrinogen-CINSTRUMENTATION LABORATORY COMPANYKQJ2016-09-23
13607450006749STA® - Fibrinogen 5DIAGNOSTICA STAGOKQJ2016-09-15