21-Hydroxylase Autoantibody ELISA

Basic Information

• Brand Name: 21-Hydroxylase Autoantibody ELISA
• Primary DI: 00840239059550
• Version / Model: EIA-5955
• Catalog Number: EIA-5955
• Company Name: DRG International Inc
• Labeler DUNS: 075150847
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-26
• Public Version: 1
• Public Version Date: 2023-09-04
• Public Version Status: New
• Public Device Record Key: 1c50e6d6-0d84-46d1-baf2-42bb7e934fdc

Device Description

The Quantitative Determination of Total Thyroxine Concentration in Human Serum or Plasma by a Microplate Enzyme Immunoassay

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PCG	21-Hydroxylase Antibody (21-Ohab)	Immunology	866.5660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
54863	Adrenal antibody IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of antibodies to the adrenal gland in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00840239059550	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K121046	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius