SPIFE Nexus IFE-9/15 Antisera Kit

GUDID M5255527440

HELENA LABORATORIES CORPORATION

Protein electrophoresis IVD, kit, electrophoresis
Primary Device IDM5255527440
NIH Device Record Key8e3e01f7-a8b7-4046-aa97-ef9f185fa314
Commercial Distribution StatusIn Commercial Distribution
Brand NameSPIFE Nexus IFE-9/15 Antisera Kit
Version Model Number552744
Company DUNS079396131
Company NameHELENA LABORATORIES CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com
Phone+1(800)231-5663
Emailhelena@helena.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM5255527440 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

CFFImmunoelectrophoretic, Immunoglobulins, (G, A, M)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-10-07
Device Publish Date2024-09-27

Devices Manufactured by HELENA LABORATORIES CORPORATION

M5255527370 - SPIFE Nexus IFE-6 Antisera Kit2024-10-07
M5255527440 - SPIFE Nexus IFE-9/15 Antisera Kit2024-10-07
M5255527440 - SPIFE Nexus IFE-9/15 Antisera Kit2024-10-07
M52594190 - IFE IgD Antiserum2024-10-07
M52594200 - IFE IgE Antiserum2024-10-07
M52594220 - IFE Free Kappa Light Chain Antiserum2024-10-07
M52518360 - V8 Urine Preparation Buffer2023-09-18
M5255526930 - SPIFE Nexus Split Beta SPE - 80, 100 Gel Kit2023-09-18
M52510680010 - SPIFE Touch, CSA 2015 (120V)2023-09-11

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