SPIFE Alkaline Phosphatase Reagent Kit

Primary DI
M5255520550
Brand
SPIFE Alkaline Phosphatase Reagent Kit
Company
HELENA LABORATORIES CORPORATION
Model
552055
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
CINELECTROPHORETIC SEPARATION, ALKALINE PHOSPHATASE ISOENZYMES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CINElectrophoretic Separation, Alkaline Phosphatase IsoenzymesClinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K020625000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K020625000SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346Helena Laboratories2002-05-06CIN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M5255520550PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Alkaline phosphatase (ALP) isoenzyme 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 quantitative measurement of one or multiple alkaline phosphatase (ALP) isoenzymes 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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