FDA.reportPublic FDA data

V8 Velocity CE Analyzer (110V) Not Inpeco Ready

Primary DI
M52518000000
Brand
V8 Velocity CE Analyzer (110V) Not Inpeco Ready
Company
HELENA LABORATORIES CORPORATION
Model
1800000
Published
2016-09-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K111369000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K111369000THE HELENA V8 IMMUNODISPLACEMENT KITHelena Laboratories Uk, Ltd.2012-06-26CFF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52518000000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Electrophoresis analyser IVD, automatedAn electrically-powered laboratory instrument or system intended to be used for the qualitative and/or quantitative in vitro determination of various molecules (e.g., DNA, RNA, proteins) in a clinical specimen based on their size, ionic charge and/or rate of migration through an electrically charged field. The device operates with minimal technician involvement and complete automation of all procedural steps.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)231-5663helena@helena.com

Regulatory Flags#

DUNS number
836287433
Device count
1
Serial number
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
M52518000010V8 Velocity CE Analyzer (110V) Inpeco ReadyHELENA LABORATORIES CORPORATIONCFF2016-09-30
M52518030V8 Immunodisplacement KitHELENA LABORATORIES CORPORATIONCFF2016-09-24