STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSA KR6010

GUDID B126KR60100

A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum.

KRONUS, INC.

Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay Immunoglobulin G subclass (IgG subclass) IVD, kit, radioimmunoassay
Primary Device IDB126KR60100
NIH Device Record Key82ed935a-5e4f-4823-8cac-fd2b07d6bfaf
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSA
Version Model NumberKR6010
Catalog NumberKR6010
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
HIBCCB126KR60100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PCG21-Hydroxylase Antibody (21-Ohab)

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSA]

B126KR60150A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxyla
B126KR60100A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxyla

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