SPIFE Vis Cholesterol Kit

Primary DI
M5255526140
Brand
SPIFE Vis Cholesterol Kit
Company
HELENA LABORATORIES CORPORATION
Model
552614
Published
2017-03-17
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
JHOELECTROPHORETIC SEPARATION, LIPOPROTEINS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JHOElectrophoretic Separation, LipoproteinsClinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000603000SPIFE CHOLESTEROL PROFILE KITHelena Laboratories2000-04-17JHO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5255526140PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Protein electrophoresis IVD, kit, electrophoresisA collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method.

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
03607360030073HYDRAGEL LIPO + Lp(a) K20SEBIAJHO2022-12-12
03607360041048HYDRAGEL 7 LIPO + Lp(a)SEBIAJHO2022-12-12
03607360041147HYDRAGEL 7 LIPOPROTEIN(E)SEBIAJHO2022-12-12
03607360041161HYDRAGEL 7 LDL/HDL CHOL DIRECTSEBIAJHO2022-12-12
03607360041246HYDRAGEL 15 LIPO + Lp(a)SEBIAJHO2022-12-12
03607360041352HYDRAGEL 15 LDL/HDL CHOL DIRECTSEBIAJHO2022-12-12
03607360041390HYDRAGEL 30 LDL/HDL CHOL DIRECTSEBIAJHO2022-12-12
03607360041444HYDRAGEL 30 LIPO + Lp(a)SEBIAJHO2022-12-12
00896863002318Liposure Serum Lipoprotein Control Level 1 4x0.5mLQUANTIMETRIX CORPORATIONJHO2018-09-26
00896863002325Lipoprint System Buffer 4x16.5gQUANTIMETRIX CORPORATIONJHO2018-09-26
00896863002332Lipoprint LDL Subfractions Kit 4x25 testsQUANTIMETRIX CORPORATIONJHO2018-09-26
M52539000Titan III Lipo (60 x 76 mm)HELENA LABORATORIES CORPORATIONJHO2017-03-17
M52550450Coolant Sponges (10/pkg)HELENA LABORATORIES CORPORATIONJHO2017-03-17
M52553220Lipoprotein Stain (1 x 2.8 g Powder)HELENA LABORATORIES CORPORATIONJHO2017-03-17
M5255519190SPIFE Vis Cholesterol KitHELENA LABORATORIES CORPORATIONJHO2017-03-17
M5255519410SPIFE Vis Cholesterol Reagent KitHELENA LABORATORIES CORPORATIONJHO2017-03-17
M5255519910SPIFE Lipoprotein Gel KitHELENA LABORATORIES CORPORATIONJHO2017-03-17
M5255520030QUICKGEL Cholesterol Gel KitHELENA LABORATORIES CORPORATIONJHO2017-03-17
M5255523630QUICKGEL Lipoprotein Gel KitHELENA LABORATORIES CORPORATIONJHO2017-03-17
M5255526080SPIFE Lipoprotein Gel KitHELENA LABORATORIES CORPORATIONJHO2017-03-17
05391516743938Trinity BiotechCLARK LABORATORIES, INC.JHO2016-09-23