Ultra-sensitive Estradiol RIA

Basic Information

• Brand Name: Ultra-sensitive Estradiol RIA
• Primary DI: 15099590211523
• Version / Model: DSL4800
• Catalog Number: DSL4800
• Company Name: IMMUNOTECH s.r.o.
• Labeler DUNS: 360561849
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-07-06
• Public Version: 1
• Public Version Date: 2023-07-14
• Public Version Status: New
• Public Device Record Key: 9a84fcf3-81ed-488b-8c40-74bf8e7fcfa9

Device Description

Ultra-sensitive Estradiol RIA

Device Characteristics

• Single Use: No
• 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
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	862.1260	1

GMDN Terms

Code	Name	Definition	Implantable	Status
54151	Estradiol (oestradiol) (E2) IVD, kit, radioimmunoassay	A collection of reagents and other associated materials intended to be used for the quantitative measurement of the estrogen (oestrogen) hormone estradiol (oestradiol) in a clinical specimen, using a radioimmunoassay method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	15099590211523	GS1

Premarket Submissions

Submission Number	Supplement Number
K953605	000