FDA.reportPublic FDA data

Antisera to Human Immunoglobulins Pentavalent (G, A, M, D, E)

Primary DI
M52592510
Brand
Antisera to Human Immunoglobulins Pentavalent (G, A, M, D, E)
Company
HELENA LABORATORIES CORPORATION
Model
9251
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52592510PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polyvalent human immunoglobulin antibody IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of all classes of human immunoglobulin (i.e, IgA, IgE, IgD, IgG, IgM) and/or specific immunoglobulin chains in a clinical specimen.

Contacts#

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

Regulatory Flags#

DUNS number
079396131
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M5255526510SPIFE A1AT Kit5526512026-06-23
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

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