FDA.reportPublic FDA data

QuickGel Acid Hemoglobin 10/20 Gel Kit

Primary DI
M5255520070
Brand
QuickGel Acid Hemoglobin 10/20 Gel Kit
Company
HELENA LABORATORIES CORPORATION
Model
552007
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
JBDSYSTEM, ANALYSIS, ELECTROPHORETIC HEMOGLOBIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JBDSystem, Analysis, Electrophoretic HemoglobinHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K992199000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K992199000ACID HEMOGLOBIN KITHelena Laboratories1999-09-21JBD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5255520070PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Inherited haemoglobinopathy 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 to evaluate a clinical specimen to diagnose, monitor or predict inherited haemoglobinopathies or haemoglobin variants, which may be associated with HbC (haemoglobin C), HbE, HbS (sickle-cell disease), Hb Lepore, Hb constant spring, alpha-thalassaemia and/or beta-thalassaemia.

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
M5255527330SPIFE Nexus Alkaline Hemoglobin Gel KitHELENA LABORATORIES CORPORATIONJBD2023-05-16
M5255527340SPIFE Nexus Acid Hemoglobin KitHELENA LABORATORIES CORPORATIONJBD2023-05-16
M52523200SPIFE 4000 Alkaline Hemoglobin Gel KitHELENA LABORATORIES CORPORATIONJBD2017-01-30
M52523220SPIFE 4000 Acid Hemoglobin KitHELENA LABORATORIES CORPORATIONJBD2017-01-30
M5255526060SPIFE Acid Hemoglobin KitHELENA LABORATORIES CORPORATIONJBD2017-01-20
M52524000Titan IV Citrate Agar PlateHELENA LABORATORIES CORPORATIONJBD2016-09-07
M52530210Titan III-H Cellulose Acetate PlateHELENA LABORATORIES CORPORATIONJBD2016-09-07
M52530220Titan III-H Cellulose Acetate PlateHELENA LABORATORIES CORPORATIONJBD2016-09-07
M52534260QuickGel Accessory KitHELENA LABORATORIES CORPORATIONJBD2016-09-07
M52534280SPIFE Hemoglobin IEF KitHELENA LABORATORIES CORPORATIONJBD2016-09-07
M52553280AA2 Hemo ControlHELENA LABORATORIES CORPORATIONJBD2016-09-07
M52553290ASA2 Hemo ControlHELENA LABORATORIES CORPORATIONJBD2016-09-07
M52553300AFSA2 Hemo ControlHELENA LABORATORIES CORPORATIONJBD2016-09-07
M52553310AFSC Hemo ControlHELENA LABORATORIES CORPORATIONJBD2016-09-07
M5255519510SPIFE Acid Hemoglobin KitHELENA LABORATORIES CORPORATIONJBD2016-09-07
M5255519770SPIFE Alkaline Hemoglobin Gel KitHELENA LABORATORIES CORPORATIONJBD2016-09-07
M5255521100QuickGel Alkaline Hemoglobin Gel KitHELENA LABORATORIES CORPORATIONJBD2016-09-07
M5255521340QuickGel Applicator Blade and Shallow Well CupsHELENA LABORATORIES CORPORATIONJBD2016-09-07
M52558020Supre-Heme BufferHELENA LABORATORIES CORPORATIONJBD2016-09-07
M52558050Electra HR BufferHELENA LABORATORIES CORPORATIONJBD2016-09-07