FDA.reportPublic FDA data

Normal HbA2 Quik Column Control

Primary DI
M52553390
Brand
Normal HbA2 Quik Column Control
Company
HELENA LABORATORIES CORPORATION
Model
5339
Published
2016-09-07
Public version status
Update
Distribution status
Not 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
JCMCONTROL, HEMOGLOBIN, ABNORMAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JCMControl, Hemoglobin, AbnormalHematology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K820787000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K820787000HELENA ABNORMAL HBA2 QUIK COLUMN CONTROLHelena Laboratories1982-04-08JCM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52553390PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Inherited haemoglobinopathy IVD, controlA material which is used to verify the performance of an assay intended to be 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
03607360047576CAPI 3 NEONAT Hb AF ControlSEBIAJCM2024-04-30
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03607360047583Hb AFSA2 CONTROL (1)SEBIAJCM2023-07-27
03607360047590Hb AFSA2 CONTROL (5)SEBIAJCM2023-07-27
06438147385478RESOLVE Hb FACS Control kitWallac OyJCM2023-04-17
B115ABCARD11371Advin Multi-Drug Screen Test ADVIN BIOTECH, INC.JCM2021-12-17
09421902348051Tosoh USCANTERBURY SCIENTIFIC LIMITEDJCM2018-11-02
09421902348105Tosoh EUCANTERBURY SCIENTIFIC LIMITEDJCM2018-11-02
09421902348020ExtendSURECANTERBURY SCIENTIFIC LIMITEDJCM2018-09-20
09421902348037ExtendSURECANTERBURY SCIENTIFIC LIMITEDJCM2018-09-20
09421902348044ExtendSURECANTERBURY SCIENTIFIC LIMITEDJCM2018-09-20
00847661000884LyphochekBIO-RAD LABORATORIES, INC.JCM2016-09-12
00847661002093LyphochekBIO-RAD LABORATORIES, INC.JCM2016-09-12
M52553330Abnormal HbA2 Quik Column ControlHELENA LABORATORIES CORPORATIONJCM2016-09-07
05391516744393Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516744409Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516748315Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06
05391516748322Trinity BiotechPRIMUS CORPORATIONJCM2016-09-06