AccessGUDID - DEVICE: ESTR-S-US (03770024321586)

GUDID

Device Identifier (DI) Information

Brand Name: ESTR-S-US
Version or Model: ESTR-S-US
Commercial Distribution Status: In Commercial Distribution
Catalog Number: ESTR-S-US
Company Name: CISBIO BIOASSAYS

Primary DI Number: 03770024321586
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 261769626 *Terms of Use

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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CHP	Radioimmunoassay, Estradiol

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Handling Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 100 tests

Device Record Status

Public Device Record Key: 29e3b89b-9a95-487e-b331-5e40dda9d73f
Public Version Date: December 15, 2021
Public Version Number: 1
DI Record Publish Date: December 07, 2021