KRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit KR7755

GUDID B126KR77550

An enzyme linked immunosorbent assay for the quantitative determination of autoantibodies against tyrosine phosphatase (IA-2) in human serum

KRONUS, INC.

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Primary Device IDB126KR77550
NIH Device Record Keyb6397fbe-6c83-4e36-b7d5-80f0ce8fa373
Commercial Distribution StatusIn Commercial Distribution
Brand NameKRONUS IA-2 Autoantibody (IA-2Ab) ELISA Kit
Version Model NumberKR7755
Catalog NumberKR7755
Company DUNS181070814
Company NameKRONUS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
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

Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com
Phone800-457-6687
Emailkronus@kronus.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB126KR77550 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OIFTyrosine Phosphatase (Ia-2) Autoantibody Assay

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number2
Public Version Date2018-07-06
Device Publish Date2018-03-22

Devices Manufactured by KRONUS, INC.

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