FDA.reportPublic FDA data

SPIFE ImmunoFix-15 Gel Kit

Primary DI
M5255525590
Brand
SPIFE ImmunoFix-15 Gel Kit
Company
HELENA LABORATORIES CORPORATION
Model
552559
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
CFFIMMUNOELECTROPHORETIC, IMMUNOGLOBULINS, (G, A, M)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)Immunology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973040000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973040000SPIFE IFE-6Helena Laboratories1998-01-02CFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5255525590PrimaryHIBCC0

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
03607360043165ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 & 9 IF MAXI-KIT (DYNAMIC MASK)SEBIACFF2026-01-09
03607360043875HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)SEBIACFF2026-01-09
03607360048160ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 4 IF MAXI-KIT (STANDARD MASK)SEBIACFF2026-01-09
03607360048177ANTISERA AND FIXATIVE SOLUTION FOR HYDRAGEL 9 IF MAXI-KIT (STANDARD MASK)SEBIACFF2026-01-09
03607360048191ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT(STANDARD MASK)SEBIACFF2026-01-09
03607360043196ANTISERUM AND FIXATIVE SOLUTION FOR HYDRAGEL 12 IF Penta MAXI-KIT (DYNAMIC MASK)SEBIACFF2026-01-08
03607360043868HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)SEBIACFF2026-01-08
03607360043899HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (DYNAMIC MASK)SEBIACFF2026-01-08
03607360048863HYDRAGEL 4 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)SEBIACFF2026-01-08
03607360048870HYDRAGEL 9 IF MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)SEBIACFF2026-01-08
03607360048894HYDRAGEL 12 IF Penta MAXI-KIT WITHOUT ANTISERUM (STANDARD MASK)SEBIACFF2026-01-08
M5255527370SPIFE Nexus IFE-6 Antisera KitHELENA LABORATORIES CORPORATIONCFF2024-09-27
M5255527440SPIFE Nexus IFE-9/15 Antisera KitHELENA LABORATORIES CORPORATIONCFF2024-09-27
03607360026014ANTISERA CAPI 3 IT (10)SEBIACFF2023-11-29
03607360026021Sample Diluent CAPI 3 IT (10)SEBIACFF2023-11-29
03607360046425Hydrashift 2 4 isatuximabSEBIACFF2022-12-08
M5255526940SPIFE Nexus IFE-6 Gel KitHELENA LABORATORIES CORPORATIONCFF2022-05-26
M5255526950SPIFE Nexus IFE-9 Gel KitHELENA LABORATORIES CORPORATIONCFF2022-05-26
M5255526970SPIFE Nexus Antisera 9/15 KitHELENA LABORATORIES CORPORATIONCFF2022-05-25
M5255527030SPIFE Nexus IFE-6 Antisera KitHELENA LABORATORIES CORPORATIONCFF2022-05-25
03607360046395HYDRASHIFT 2 4 daratumumab 20 testsSEBIACFF2019-07-01
M52518010000V8 E-Class Velocity CE Analyzer (220V)HELENA LABORATORIES CORPORATIONCFF2018-06-19
M52518200V8 WASTE DRAWER PACKHELENA LABORATORIES CORPORATIONCFF2018-06-19
M52518250000V8 Nexus CE Analyzer (115V/230V)HELENA LABORATORIES CORPORATIONCFF2018-06-19
03607360021002CAPILLARYS IMMUNOTYPINGSEBIACFF2018-01-24
03607360023006IT/IF ControlSEBIACFF2018-01-24
03607360026007CAPI 3 IMMUNOTYPINGSEBIACFF2018-01-24
M52518210V8 Gel IFE Diluent Barcode LabelsHELENA LABORATORIES CORPORATIONCFF2016-09-30
M52518000000V8 Velocity CE Analyzer (110V) Not Inpeco ReadyHELENA LABORATORIES CORPORATIONCFF2016-09-30
M52518000010V8 Velocity CE Analyzer (110V) Inpeco ReadyHELENA LABORATORIES CORPORATIONCFF2016-09-30