STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSA KR6015

GUDID B126KR60150

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

• Primary Device ID: B126KR60150
• NIH Device Record Key: a2a230a3-c914-49d5-93f0-79f29e42dd5d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STEROID 21-HYDROXYLASE ANTIBODY (21-OHAb) RIA ASSA
• Version Model Number: KR6015
• Catalog Number: KR6015
• Company DUNS: 181070814
• Company Name: KRONUS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 800-457-6687
• Email: kronus@kronus.com
• Phone: 800-457-6687
• Email: kronus@kronus.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B126KR60150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K121046

FDA Product Code

• PCG: 21-Hydroxylase Antibody (21-Ohab)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23

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

• B126KR60150: A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxyla
• B126KR60100: A radioimmunoassay for the semi-quantitative determination of antibodies to steroid 21-hydroxyla