TITAN GEL IEP Kit (10 gels)

Primary DI
M52530470
Brand
TITAN GEL IEP Kit (10 gels)
Company
HELENA LABORATORIES CORPORATION
Model
3047
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
JZRSUPPORT GELS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JZRSupport GelsImmunology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K831603000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K831603000TITAN GE/IEPLATEHelena Laboratories1983-07-07JZR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M52530470PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Protein electrophoresis IVD, kit, electrophoresisA collection of reagents and other associated materials intended to be used for determining the qualitative and/or quantitative separation of proteins in a clinical specimen, using an electrophoresis method.

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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