FDA.reportPublic FDA data

Coagulation S.A.C.-2 (Specialty Assay Control)

Primary DI
M52553020
Brand
Coagulation S.A.C.-2 (Specialty Assay Control)
Company
HELENA LABORATORIES CORPORATION
Model
5302
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
GGCCONTROL, PLASMA, ABNORMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GGCControl, Plasma, AbnormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100103000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100103000SPECIALTY ASSAYED CONTROL-2Helena Laboratories2010-12-15GGC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52553020PrimaryHIBCC0

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
M52553010Coagulation S.A.C.-1 (Specialty Assay Control)53012016-09-07
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
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00842768019685LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2024-03-29
00630414640167Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2024-03-25
00842768019470Dade Ci-Trol Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2024-03-25
00630414639703Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2024-02-19
00842768018589Control Plasma PSiemens Healthcare Diagnostics Products GmbHGGC2024-02-19
00815696021341George King SysCOR-40 Control KitGEORGE KING BIO-MEDICAL, INCGGC2023-03-15
00815696021143George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00815696021150George King Factor XIII Deficient PlasmaGEORGE KING BIO-MEDICAL, INCGGC2020-03-27
00817869020243Animal Plasma Control Level IIANALYTICAL CONTROL SYSTEMS INCGGC2019-01-31
00815696021112George King Positive Lupus AnticoagulantGEORGE KING BIO-MEDICAL, INCGGC2018-06-22
00815696021051George King AbCOR Convenience KitGEORGE KING BIO-MEDICAL, INCGGC2017-04-17
00815696021068George King AbCOR Convenience KitGEORGE KING BIO-MEDICAL, INCGGC2017-04-17
00630414023502LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2017-02-15
00630414023519LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2017-02-15
10859394006061PlasmaCon NR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006078PlasmaCon L1R 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006085PlasmaCon L2R 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006108LupoTek Detectin VLR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006115LupoTek Correctin VLR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006122PlasmaCon LAR 2 DIAGNOSTICS, INC.GGC2016-11-15
10859394006139PlasmaCon LAR 2 DIAGNOSTICS, INC.GGC2016-11-15
00842768004056Dade® Ci-Trol® Coagulation Control Level 1Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768006838Berichrom® Heparin UF Control 2Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768006852Berichrom® Heparin LMW Control 2Siemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768008351LA Control HighSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24
00842768008368LA Control LowSiemens Healthcare Diagnostics Products GmbHGGC2016-09-24