FDA.reportPublic FDA data

Coagulation S.A.C.-1 (Specialty Assay Control)

Primary DI
M52553010
Brand
Coagulation S.A.C.-1 (Specialty Assay Control)
Company
HELENA LABORATORIES CORPORATION
Model
5301
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
GIZPLASMA, CONTROL, NORMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GIZPlasma, Control, NormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K941737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K941737000SPECIALTY ASSAYED CONTROL-1Helena Laboratories1994-10-07GIZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52553010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Multiple coagulation marker IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative determination of multiple makers associated with coagulation including coagulation factors, intermediates and/or their activated components, functional tests [activated partial thromboplastin time (APTT), thrombin time (TT), prothrombin time (PT)] and/or physiological anticoagulants (e.g., antithrombin III) 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
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
M5255526930SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit5526932023-09-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GIZ2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GIZ2016-11-15
00842768006821Berichrom® Heparin UF Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00842768006876Berichrom® Heparin LMW Control 1Siemens Healthcare Diagnostics Products GmbHGIZ2016-09-24
00843876000053CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00843876000060CRYOcheck™ Reference Control NormalPrecision Biologic IncGIZ2016-09-23
00850201006147LAtrol NORMAL CONTROL PLASMABiomedica ADI Inc.GIZ2016-09-20
00845275000559Thermo Scientific Pacific Hemostasis®Fisher DiagnosticsGIZ2016-09-16
13607450006756STA® - UnicalibratorDIAGNOSTICA STAGOGIZ2016-09-15
15391521420777TriniCHECK™ D-Dimer 1TCOAG IRELAND LIMITEDGIZ2016-09-12
00855360006243REAADS Coagulation Control 1CORGENIX MEDICAL CORPORATIONGIZ2016-07-14