ESTR-US

Basic Information

• Brand Name: ESTR-US
• Primary DI: 03770024321593
• Version / Model: ESTR-US
• Catalog Number: ESTR-US
• Company Name: CISBIO BIOASSAYS
• Labeler DUNS: 261769626
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-12-07
• Public Version: 1
• Public Version Date: 2021-12-15
• Public Version Status: New
• Public Device Record Key: 190d0fcb-505e-4894-8bfa-aabec6390c96

Device Description

Radioimmunometric assay kit for the quantitative determination of low levels of estradiol in human samples. Contain enough reagents for 100 tests. For in vitro diagnostic.

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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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	03770024321593	GS1

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			100 tests

Storage Conditions

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