FDA.reportPublic FDA data

CK/LD Isoenzyme Control (5 x 2 mL)

Primary DI
M52551340
Brand
CK/LD Isoenzyme Control (5 x 2 mL)
Company
HELENA LABORATORIES CORPORATION
Model
5134
Published
2017-03-17
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
JJTENZYME CONTROLS (ASSAYED AND UNASSAYED)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JJTEnzyme Controls (Assayed And Unassayed)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K821981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K821981000TITAN GEL CPK/LDH ISOENZYME CONTROLHelena Laboratories1982-07-22JJT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52551340PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Protein electrophoresis IVD, controlA material which is used to verify the performance of an assay intended to be 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
Lot or batch
true
Expiration date on label
true

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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
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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

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