AccessGUDID - DEVICE: DBC Free Estriol ELISA (B261CANE6400)

GUDID

Device Identifier (DI) Information

Brand Name: DBC Free Estriol ELISA
Version or Model: CAN-E-640
Commercial Distribution Status: In Commercial Distribution
Catalog Number: CAN-E-640
Company Name: Diagnostics Biochem Canada Inc

Primary DI Number: B261CANE6400
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 207718438 *Terms of Use

Device Description: For the quantitative measurement of Free Estriol in human serum by an ELISA (Enzyme-Linked Immunosorbent Assay). For in vitro diagnostic use.

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:	Yes
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?
63779	Free estriol (oestriol) 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 free estriol (oestriol) in a clinical specimen, using an enzyme immunoassay (EIA) method. It is typically measured in maternal blood, urine or saliva as a marker of foetal health, gestational age, or fetoplacental distress typically in pregnancies complicated by diabetes, hypertension, or prolonged gestation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
CGI	Radioimmunoassay, Estriol

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
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 72adf2f7-1325-454a-9593-8788543b5b8a
Public Version Date: November 23, 2022
Public Version Number: 1
DI Record Publish Date: November 15, 2022