KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBOD KR7590

GUDID B126KR75900

A radioimmunoassay for the semi-quantitative determination of blocking antibodies to the acetylcholine receptor (AChR) in human serum.

KRONUS, INC.

Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay
Primary Device IDB126KR75900
NIH Device Record Key72d26dc6-33d5-43bb-8fe5-b72c4064aac6
Commercial Distribution StatusIn Commercial Distribution
Brand NameKRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBOD
Version Model NumberKR7590
Catalog NumberKR7590
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 Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB126KR75900 [Primary]

FDA Product Code

NSTAutoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2018-03-29
Device Publish Date2016-09-23

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