FDA.reportPublic FDA data

Hemolysate Reagent

Primary DI
M52551250
Brand
Hemolysate Reagent
Company
HELENA LABORATORIES CORPORATION
Model
5125
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
GKAABNORMAL HEMOGLOBIN QUANTITATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GKAAbnormal Hemoglobin QuantitationHematology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52551250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Protein electrophoresis 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 determining the qualitative and/or quantitative separation of proteins by electrophoresis, 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
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
03607360012444CAPILLARYS 3 DBSSEBIAGKA2024-04-30
03607360025062CAPI 3 NEONAT HbSEBIAGKA2024-04-30
03607360025635CAPI 3 NEONAT HEMOLYSING SOLUTIONSEBIAGKA2024-04-30
03607360025789CAPILLARYS 3 DBS MICROPLATESSEBIAGKA2024-04-30
00847817000560VARIANT nbs Newborn ScreeningBIO-RAD LABORATORIES, INC.GKA2023-01-31
00847817007057Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007064Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007071Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007156Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007170Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
00847817007187Hemoglobin Variants SystemBIO-RAD LABORATORIES, INC.GKA2020-06-24
03607360020074CAPILLARYS HEMOGLOBINSEBIAGKA2018-01-24
03607360022078MINICAP HEMOGLOBINSEBIAGKA2018-01-24
05391516744102Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516744119Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516748179Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
05391516748186Trinity BiotechPRIMUS CORPORATIONGKA2016-09-20
00847817007354VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008276VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008283VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008306VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008313VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008344VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
00847817008351VARIANT nbsBIO-RAD LABORATORIES, INC.GKA2016-09-12
M52551270Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
M52551280Hemolysate ReagentHELENA LABORATORIES CORPORATIONGKA2016-09-07
05391516744195Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744201Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744232Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06
05391516744249Trinity BiotechPRIMUS CORPORATIONGKA2016-09-06